Clinical Development Resume Samples

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L Deckow

Lupe

Deckow

937 Lindsey Fork

San Francisco

+1 (555) 116 5780

937 Lindsey Fork

San Francisco

Phone

p +1 (555) 116 5780

Experience Experience

Dallas, TX

Clinical Development Specialist

Dallas, TX

Reichert and Sons

Dallas, TX

Clinical Development Specialist

Provide assistance for B+L customers via telephone and email
Work with Electrophysiologists, Cardiologists, Cardiac Technicians and decision makers in the medical community
Works with TSR to design and develop base education/training materials to support staff training and continued education
Visit and develop network with existing and potential customers
Providing case support for heart mapping systems
Navigation/AF KOL management
Monitors product performance during conditional evaluations

Phoenix, AZ

Global Head of Clinical Development

Phoenix, AZ

Prohaska Inc

Phoenix, AZ

Global Head of Clinical Development

Responsible for designing and executing clinical development plans across the global businesses
Contribute to the development of new indications for existing products
Leading a team of Medical Directors, based in various geographies
Communicate internally and externally clinical study outcomes, including scientific publications
Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
Complete all planned Quality & Compliance training within the defined deadlines
To provide coaching and leadership to his/her team

present

Dallas, TX

Director of Clinical Development

Dallas, TX

Langosh-Halvorson

present

Dallas, TX

Director of Clinical Development

present

Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials
Play a leadership role in managing multiples of Phase I through Phase IV clinical research trials across all functional areas of the drug development process
The successful candidate will have oversight for ongoing and planned product trials within the Inflammation Therapeutic area
The Clinical Research MD will report to a more senior member of the Inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
The successful candidate will have oversight for ongoing and planned product trials within the Liver Disease therapeutic area
Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans

Education Education

Bachelor’s Degree in Life Sciences

University of Pittsburgh

Bachelor’s Degree in Life Sciences

Skills Skills

Basic mathematics and analysis
Ability to travel up to 25% of the time
Proficiency in using Microsoft Office programs, including but not limited to Word, Excel, PowerPoint and Outlook
Ability to collaborate in a team environment
Ability to formulate reports and present findings
Flexibility to work occasional nights and weekends
2+ years’ experience writing reports
Effective written and oral communication skills
Experience in an OR environment
Experience giving presentations

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15 Clinical Development resume templates

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Clinical Development Manager Resume Examples & Samples

Minimum 5 years of clinical research related experience, e.g., as a Clinical Development (or Clinical Trials) manager preferably in the field of CNS, psychiatry/psychology, or addiction
Extensive Phase 2 and 3 clinical trial experience both U.S. and ex-U.S is a definite plus
Bachelor’s degree in a relevant scientific/biomedical field with appropriate experience; advance degree preferred but not required
Previous pharmaceutical industry experience is highly desirable

Manager Non Clinical Development Ops Resume Examples & Samples

60% Analytical Subject Matter Expert
In support of product development, apply broad and deep analytical knowledge and experience to the material characterization and testing of APIs and drug products
Apply knowledge and direct experience to ensure the appropriate analytical methodologies are in place and fit-for-purpose to properly support the development projects
Provide technical guidance for troubleshooting / investigating complex analytical issues. Quickly and effectively resolve complex analytical issues and deviations / investigations
Apply statistical analysis for interpretation of analytical and stability data
Author and/or review analytical methods and associated development, qualification, validation and transfer protocols and reports
Manage and oversee stability and analytical studies for projects. This includes authoring / reviewing protocols and reports as well as evaluating the results and leading technical discussions with project team members and external contractors
Ensure all cGMP data generated for development projects are managed and evaluated as described in relevant internal procedures and regulatory requirements
Effectively communicate complex technical issues and deliver concise presentations to management and non-technical stakeholders
Actively contribute to the preparation and coordination of internal audits and regulatory inspections
Provide technical input for selecting external Shire contractors and manage day-to-day contractor activities for respective projects
Maintain a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses
Create and enhance collaborative and trusting relationships internally and with personnel at Contract Research Organizations (CROs)
20% Regulatory Submissions
Author and/or review relevant API and drug product CMC sections for global regulatory submissions (IND/CTA and NDA/MAA and annual reports) and ensure sections meet submission ready standards regarding content and format
Assist with responses to regulatory agencies regarding stability and analytical-related inquiries
Maintain awareness of current trends regarding global regulatory CMC requirements through literature and conference attendance
20% Documentation / Compliance
Ensure analytical test methods, development reports, and specifications are compliant with internal procedures and regulatory requirements
Assist with the implementation of departmental processes, procedures and policies
Maintain adherence to departmental and quality systems, such as SOP training records, deviations/investigations, CAPAs, and Change Controls
Requires an advanced degree (MS or PhD) in Chemistry, Chemical Engineering, Pharmacy or closely related field and at least 6 years of relevant analytical experience within the Pharmaceutical Industry or a BS degree with 10 years of relevant analytical experience
The following items are essential

Clinical Development Lead Resume Examples & Samples

80%
Provide medical monitoring support for the on-going clinical trial and long-term outcome study
Other clinical responsibilities

Clinical Development Specialist Resume Examples & Samples

Clinical Strategy External Deployment (including New Products - NP)
Supervise external HCP educational courses, personally do field support/launch activities and co-operate with the field representatives to drive Clinical Strategy External Deployment. Create success in the adoption of NP and maximization of its usage since the launch Establish relationship with NP users and Key Opinion Leaders across Russia & CIS to link NP usage with the newest clinical strategies, especially for AF treatment. Work together with Clinical Trainer to ensure a good clinical impact of NP based on current KOL usage of system and catheters
Implement marketing strategy in the field, with special focus on critical-to-success product's application
Ensure full and clear understanding and deployment of those strategies by the local field force, personal field work and professional education activities to obtain clinical application of BW products and development of therapy adoption rapid and strong. Work closely to the local Clinical Trainer & Field Representatives to maximize utilization of CARTO® 3 Systems and new technologies with focus in the AF arena
Navigation/AF KOL management
Establish a strong relationship with all Russia/CIS KOLs. Meet field representatives working with KOLs to better define support and clinical advice to/from KOLs labs. Ensure a strong communication within Russia/CIS on the most recent AF treatment options with our technologies. Maximize KOL's CARTO® 3 and new technology adoption in AF treatment
Execute Internal Clinical Training activities
Work together with Clinical Trainer to ensure complete & timely delivery of internal clinical training and respective certification. Personally participate as a trainer in internal clinical training modules. Be able to back up any activities which are executed by the Clinical Trainer. Ensure strong link between internal clinical training and representatives’ performance in the field and resulting lab behavior
Share best clinical practices and identify critical success factors
Represent together with Clinical Trainer and the others CDS/CDM the Clinical HUB within EMEA. Ensure a strong and productive Communication. Maximize assigned Territory Utilization per system

Clinical Development Manager Resume Examples & Samples

Strong knowledge of Electrophysiology with practical experience
Bachelor's degree with strong clinical knowledge and understanding
At least three years of directly related experience including one year of leadership experience
Strong time management skills & ability to handle multiple tasks and to work under pressure
Strong project management skills: previous projects and team work assignments and successful completion will represent a plus

Lead, Early Clinical Development Resume Examples & Samples

Pre-clinical plans to support the initiation of clinical trials in humans
Clinical programs conducted within timelines and budgets while ensuring regulatory compliance
CMC strategy to support CDP
Regulatory strategy to support CDP
Contribute to the development of budgets and resource forecasts for all relevant pre-clinical and clinical development activities
Matrix management of the eCDT in their area of responsibility to ensure high quality execution of CDP including adherence to timelines and budgets
Interact with other groups outside of the eCDT to ensure input into CDP where appropriate
Interact with other groups outside of the eCDT to ensure that appropriate resources are available to enable the CDP and that other departments are aligned with the CDP
Participate in strategic planning activities coordinated via the Disease Area Strategy (DAS) group
Ensure that project key project milestones/strategy are communicated to the wider teams and endorsed by senior management
Ensure clinical development programs are tracked and communicated in a consistent and effective manner
Interact with the TA’s Senior Leadership Team to ensure that the eCDT’s plans are aligned with department goals and within anticipated budgets
Ensure smooth transition of compound(s) from early development into late development
A minimum of a Master’s Degree is required
An advanced degree (PhD or MD) strongly preferred
A minimum 8 years’ experience in a relevant therapeutic area, with strong knowledge in Infectious Diseases is required
Experience in early phase clinical drug development is required
Experience of regulatory interactions is preferred
Demonstrated ability to work effectively with highly functional teams is required
Experience developing antiviral compounds in an early development setting is strongly preferred
Self-motivated and able to work independently with minimal supervision is requiredR&D

Director, Diagnostic Clinical Development Resume Examples & Samples

Within the Janssen Diagnostics organization this person will be in charge of the clinical strategy for the development of new assays as well as their implementation
Create clinical development plans in alignment with project timelines and milestones
Ensure appropriate staffing for implementing, monitoring and conducting clinical development programs for new diagnostic assays
Interacting with different stakeholders including R&D, regulatory, biostatistics and commercial to ensure all appropriate inputs are included in the development plans
Gather input from internal and external clinical and scientific experts to incorporate in development plans
Develop and provide input to research protocols for specific projects promoting the diagnostic offering in different therapeutic areas, as well as the Janssen Diagnostics message and value
Assist in publication planning, preparation and review
Build advocacy for Company existing and future products among regional and national thought leaders, including physicians, key academic centers, professional organizations, patient advocacy groups, hospital administration and payers
Represent Company at professional meetings, congresses, local symposia and partner-sponsored meetings
An MD is preferred but will consider a PhD
A minimum of 5 years of relevant industry experience in the field of diagnostic clinical development or pharmaceutical development is preferred
Strong oral and written communication skills are required
Ability to operate in a complex matrix organizational environment is required
Experience in the conduction and design of clinical trials in the device and diagnostic areas is preferred
Expertise in diagnostic oncology would be highly valued
Proven ability to manage multidisciplinary teams is preferred
Ability to travel up to 20% (domestic and international) is requiredClinical Research non-MD

VP, Clinical Development Rheumatology Resume Examples & Samples

Consultation for early phase (phase 0/I) clinical development for selected NMEs across multiple Rheumatology indications
Work closely with Disease Area Stronghold leadership in informing, influencing and implementing strategies for all aspects of clinical development
Design, implementation and reporting of phase II and III clinical trials and support of regulatory submissions
Advice to Discovery, Clinical Pharmacology, Medical Affairs and Commercial, Business Development and Global Clinical Development Organization, each of these within the Rheumatology clinical discipline and within Immunology Development
Collaboration support with partners for compounds in Rheumatology indications
Organizational leadership responsibility for staff Rheumatology Therapy Area
Team leadership/membership responsibilities, including Rheumatology Clinical Team and selected Compound Development Teams (either directly, or through reports)
Member of Immunology Development Senior Leadership Team, which oversees departmental talent strategy and talent development, ensures compliance and on time departmental training, drives innovation, and manages rewards, recognition, and promotions
An MD is required for this position
Certification in Rheumatology subspecialty is preferred
At least 10 years combined clinical/biomedical research experience in the academic or pharmaceutical industry settings is required
Strong leadership and collaborative skills are requiredClinical Research MD

Medical Director Late Stage Clinical Development Resume Examples & Samples

Design the clinical development strategy to clinically demonstrate nutrition and health benefits for Nestlé products
Design and plan the over-all scientific package (literature, pre-clinical, clinical, etc.) that provides the evidence to proof the health benefits of Nestlé products and by doing so support the Nestlé business units in their Nutrition, Health and Wellness journey
Supervise the execution of the medical scientific evidence plan, provide ongoing medical scientific input and propose adaptations and corrections when necessary
Build and maintain a medical scientific network internally and externally (KOLs) around health benefit focus areas for F&B
Supports Business Units with medical scientific expertise for the translation of health concepts into product development and messaging
Supervise the design and the execution of the clinical trial plan in collaboration with the head of clinical operations
Supervise the development and execution of a scientific communication plan
Build medical scientific network internally and externally (KOLs) around health benefit focus areas that can provide
Medical Doctor, preferably with specialization in internal medicine or paediatrics. Additional experience in metabolic and cardiovascular diseases, immunology, gastroenterology or mobility would be a plus
PhD and/or MBA will be considered and advantage
Min 5 years international experience in clinical R&D in Nutrition, Pharma or CRO organization
Understanding of nutrition and health environment, including regulatory aspects of nutritional products
Full knowledge of state of the art in the field of early clinical research & development
Business acumen and capability of translating scientific concepts into business opportunities and scientific messages for professionals and consumers
Project and stakeholder management experience
Ability to manage resources and budgets in a matrix organization and provide functional leadership; functional leadership and people development skills
Fluency in English, knowledge of one or more major languages is a plus

Medical Director Early Clinical Development Resume Examples & Samples

Participate in designing the early development clinical strategy to develop nutrition and health benefits for Nestlé products
Identify and demonstrate to Proof of Concept the clinical benefits of Nestlé products that are most relevant to consumers and by doing so optimally support the Nestlé business units
Design, plan and deliver Early Clinical Development plans for products/ingredients that provide a solid base for late stage development programs of final products
Provide scientific / medical recommendations within networks and where appropriate cross-functional to improve performance and quality in clinical substantiation of health benefits
Provide critical reviews of scientific/ technical content of projects and promote cross-fertilization of health benefit opportunities across businesses
Ensure that specific Clinical R&D expertise is developed and transferred across the organization
Liaise with Nestlé Experts, R&D functions and external collaborators to drive continuous improvements
Foster a climate of innovation, mobilize and coach people
Medical Doctor degree, preferably with specialization in one of the following therapeutic areas: internal medicine, translational medicine, clinical pharmacology
PhD and/or MBA and/or license to practice in Switzerland will be considered an advantage
Min 5 years experience in clinical R&D in Pharma, Nutrition, CRO organization in multiple clinical sites
Understanding of operational set-up of clinical substantiation plans and clinical studies in an international setting with track record for major innovation or initiatives
Full knowledge of state of the art in field of early clinical research & development
Business acumen and capability of translating scientific concepts into business opportunities
Excellent communication and networking skills at an international level
Ability to manage resources and budgets in a matrix organization

Pre-clinical Development Lead Resume Examples & Samples

Provides critical technical evaluation and input at stage gate reviews on major projects
Partner with Pre-Clinical operations to create and communicate a global vision of the business' contribution to the business goals, insuring industry leadership. Inspire team to action consistent with vision. Establish high standards and stretch goals for organization. Hold team accountable for successful completion of projects/tasks
Partner with cross functions to ensure knowledge of pre-clinical team role in product development. Ensure team members represented at project meetings
Partner with Pre-clinical operations and Project management to prioritize projects across functions around sustaining type work for our products
Proactively prioritize and balance utilization of resources allocated to project; identify opportunities to cross-train and manage across project and across global team
Identify and develop relevant core technical competencies that meet current and future needs of Baxter in the broad areas of toxicology, clinical pathology and material safety. Develop team members to lead each of the projects
Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
Provide technical skills to guide timely scientific assessment of innovative and developmental projects across Baxter-ensuring accountability and milestone achievement
Role model of Baxter 2020 cultural values
Able to develop solutions and make recommendations based on analysis
Willing to participate & contribute to efforts beyond own scope of responsibilities
Motivated to positively impact the healthcare industry and ultimately patient’s lives
Must possess strong knowledge of scientific disciplines in the life sciences and solid knowledge of related disciplines
Must possess knowledge of preclinical studies including good laboratory practice (GLP) regulations, quality system regulations to include good manufacturing practice (GMP) regulations, and general business systems
Must possess a general knowledge of applicable regulations and have relevant regulatory experience pertinent to product development and post-approval product support
Must possess strong ability to negotiate for resources and influence others internally and externally
Must be able to set strategic direction for the organization and broadly communicate the vision
Willingness and ability to successfully operate in both technical and functional management space

Senior Clinical Development Lead Resume Examples & Samples

8+ years of experience in healthcare operations, preferably in claims, claim support (coding), audit (FWA/SUI), or network management and operations
2+ years management experience preferred
Healthcare Systems Information technology background a plus
Consultative and customer facing skills preferred
ClaimsXten product and clinical content/rules knowledge preferred. Working knowledge of clinical and content rules development preferred
Integration experience preferred
Experienced driving training programs preferred
Highly collaborative, self-starter; active, problem solver and adult learner
Demonstrate the company values of Integrity, Customer Focus, Accountability, Respect and Excellence (ICARE) at all times
Expert in agile lifecycle models a plus

Associate Specialist, Clinical Development Resume Examples & Samples

Develop, review, and update clinical design control documents including technical summaries, clinical risk assessments, design of validation protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in less complex product development
Ensure successful product lifecycle management for one or two projects, including
Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance
Act as a Document Management system (e.g., Ignite) expert to team for troubleshooting, ensuring proper procedures are followed and resolving issues for documents in clinical product development
Provide support and troubleshoot for document initiation to Clinical Affairs team
Bachelor's degree in Engineering degree required
Up to 3 years of previous related experience in Class II and III medical device technologies and/or clinical studies background required
Good knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
Good understanding of pre-clinical testing protocols, hospital environments and sterile techniques
Good knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)
Good written and verbal communications skills interpersonal relationship skills
Ability to manage confidential information with discretion
Ability to manage competing priorities in a fast paced environment
Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
Participates in arranging own activities in accomplishing objectives
Contributes to the completion of sections of organizational projects and goals
Ability to build stable working relationships internally
May participate in process improvements
Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery; Experience with documentation management systems (e.g., Ignite) preferred

Director of Clinical Development Operations Resume Examples & Samples

Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
Serves as CD liaison/point-of-contact for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc., collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
Represents CD in sub-teams and addresses CD study or other program-specific questions, develops and provides input for clinical presentation slides and other materials for meetings and ongoing communications
Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as internal groups, including, research, operations, legal and business development
Where assigned, acts as primary CD liaison/point of contact for operational implementation and execution of clinical development programs from clinical research organizations (CROs) and clinical trial sites
Helps coordinate the successful completion of documents with other groups
Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews and submissions to scientific meetings and/or other appropriate venues or groups
Participates in ongoing enhancements and development of team processes, structures, and tools
Masters/Ph.D. in Biological Sciences, Pharmacology or a related scientific discipline
9+ years of clinical research and/or clinical development experience within the biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of fore mentioned.) Gene therapy and rare disease experience preferred
Understanding of US Regulatory requirements

Director of Clinical Development Resume Examples & Samples

The successful candidate will have oversight for ongoing and planned product trials within the Liver Disease therapeutic area
The Clinical Research MD will report to a more senior member of the Liver Disease clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
6+ years of relevant experience in clinical research with an MD
Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred

Director of Clinical Development Resume Examples & Samples

The clinical research physician will play a key role at all stages of development for product programs from the drug discovery stage through product registrations world-wide
The successful candidate will have oversight for ongoing and planned product trials within the Inflammation Therapeutic area
The Clinical Research MD will report to a more senior member of the Inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials
Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans
Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
Coordinates the collection and analysis of clinical data for internal analysis and review
Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections
Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings
Develops manuscripts for publication in peer-reviewed journals
Will be part of a team responsible for defending the clinical development program before regulatory authorities
Serves as a scientific and clinical resource within Gilead Clinical Research
Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff
Assists in the clinical evaluation of business development opportunities

Intern, Non-clinical Development Resume Examples & Samples

Gain understanding of importance/relevance of pharmacokinetic data to early drug development
Interact with R&D departments including Formulation Development and Analytical Development groups
Coordinate with R&D and animal lab for ongoing studies
Compile and summarize data from pharmacokinetics studies including formulation characteristics, bioanalytical data, clinical observations, etc
Assemble data that will be included in FDA submissions
College student majoring in Chemistry, Biochemistry, Biology, or a related field at an accredited college or university
1 year of experience in a laboratory environment, preferable in a pharmaceutical or biotech operation
Basic understanding of chemical and biological principals
Ability to utilize scientific information resources within the assigned area of responsibility
Good understanding of the scientific thinking in the design of experimental protocols
Basic documentation skills (e.g. notebook, reports) with attention to detail and legible handwriting
Good organizational skills (e.g. daily tasks, documentation, archived information)
Good interpersonal skills (e.g. working with members of other teams to achieve shared goals)
Good verbal and written English communication skills (e.g. able to participate in scientific discussions and written interactions)
Demonstrated computer proficiency, e.g., word processing, spreadsheets, graphing, etc
Ability to work in a methodical and organized fashion
Ability to manage multiple responsibilities with a high degree of self motivation

Director of Clinical Development Resume Examples & Samples

Play a leadership role in managing multiples of Phase I through Phase IV clinical research trials across all functional areas of the drug development process
Oversee and coordinate the operational aspects of ongoing projects to ensure corporate goals of time, cost and quality performance expectation are met
Guide clinical operations in outlining standard operating procedures (SOP) for Clinical Development that facilitate the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards
Lead and motivate clinical staff
Develop and review protocols and interact with key external opinion leaders regarding protocol development
Find investigators
Conduct investigator meetings and site visits
Implement and supervise clinical trials, including requests for eligibility and other waivers
Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of AEs, SAE and protocol deviations. Prepare SAE narratives for submission to regulatory affairs, reconciling SAE database, MedDRA and WHO coding
Advise and troubleshoot any medical problems arising at clinical sites
Interact with data management to support data entry including assistance with edits
Demonstrate leadership and interpersonal skills
Interact with senior management and product team regarding drug development strategy and plan
Interact with investigators and key opinion leaders regarding protocol development
Write protocols, IB and annual reports
Contribute to Clinical Study Reports
Write safety section of IND and NDA submissions
Help create budgets and progress reports; complete other administrative tasks as required
Medical Degree required, or PhD with significant experience in Oncology Pharmaceuticals
Requires Hematology or Oncology experience
One to three years experience in the pharmaceutical or contract research industries, or two years in academic clinical research
Knowledge of safety reporting principles, including FDA safety reporting regulations
Skill in writing narratives
Experience with safety database coding
Able to work independently, prioritize tasks efficiently and meet expected time frames
Able to perform thorough reviews of various medical and legal records in a timely manner

Associate Director of Clinical Development Resume Examples & Samples

Plays a leadership role in managing multiple Phase I through Phase IV clinical research trials across all functional areas of the drug development process
Provides medical/scientific input and advice by working closely with local Clinical Operations personnel on clinical trial(s) being conducted
Guides clinical operations in outlining the clinical development strategy for the compound
In accordance with GCP, adheres to all clinical/medical standards in compliance with industry standards
Develops and review protocols and interact with key external opinion leaders regarding protocol development
Monitors clinical trial progress including, but not limited to, study conduct, eligibility questions, review of ongoing study status and patient safety, data review and protocol deviations
Provides direction to Medical personnel and/or participates in Medical-Legal-Regulatory review of promotional materials
Advises and troubleshoots any medical problems arising at clinical sites
Interacts with data management to support data entry including assistance with edits
Demonstrates leadership and interpersonal skills
Interacts with senior management and product team regarding drug development strategy and plan
Interacts with investigators and key opinion leaders regarding protocol development
Writes protocols, investigator brochure (IB) and annual reports
Provides guidance and assistance in the interpretation of the eligibility criteria for the clinical trial
Reviews all study specific plans, including statistical analysis plan, safety analysis plan, data management plan and clinical operations monitoring plan
Responsible for ongoing review of all study documents (IB, protocol amendments, etc.)
Reviews and approves case report forms in conjunction with Data Management and Clinical Operations
Reviews and approves Informed Consent Form in conjunction with Clinical Operations and Pharmacovigilance (PVG)
Responds to inquiries from Ethics Committees and Institutional Review Boards
Provides medical input for the Clinical Study Report (CSR) and in conjunction with the core study team approves final CSR
Reviews and approves adverse event narratives in conjunction with PVG
Creates, reviews and approves a study-specific protocol deviation list along with the core study team
Reviews and assesses the progress, integrity and conduct of the clinical study throughout the course of the trial so that the safety of all patients in the study is ensured
Performs regular review of study safety listings (AEs, SAEs, etc) along with PVG to assess for development of new safety signals
Continuously reviews data from the clinical trial database to identify abnormal results, assess clinical significance, identify any efficacy and/or safety trends and determine if a specific action is necessary
Requires a Medical Degree; Hematology or Oncology experience is required
One to three years of experience in the pharmaceutical research industry, or two years in academic clinical research
Able to perform critical review of various medical, clinical, regulatory and safety documents in a timely manner
Able to interact and collaborate professionally with various departments, regulatory agencies and investigators

Senior Administrative Assistant Clinical Development Resume Examples & Samples

Schedule management for multiple calendars
Email correspondence with internal counterparts, corporate travel, external investigators, partners, customers, vendors, etc
Schedule meetings across various departments, with internal personnel and external investigators, customers, vendors, including but not limited to the setup of conference rooms, teleconferences and WebEx meetings
Schedule and manage all domestic and international travel and accommodations, meetings and meeting logistics
Register and confirm individuals for various conferences throughout the year
Plan, organize, participate in meetings and events such as, but not limited to onsite and offsite team meetings, clinical department and all-company events
Prepare various reports, binders and print-outs as needed
Organize, reconcile and submit expense reports in Concur
Review and approve incoming invoices
Point of contact for out of office notifications, facilities and IT requests
Responsible for new hire setup and on-boarding; dissemination of information, tools and resources for newly hired team member
General administrative duties - copy, file, fax, order supplies, data entry, FedEx shipments, etc
5 or more years of administrative assistant experience supporting executive level management
Possess strong leadership skills and a will to take initiative when needed
Possess outstanding organizational and communication skills – both verbally and written
Ability to multi-task and set priorities under tight deadlines and urgent requests
Ability to handle sensitive information and maintain high levels of confidentiality
Highly detail oriented and maintain high level of accuracy
Demonstrate ability to problem solve and recommend solutions
Must have ability to be flexible, creative and resourceful
Ability to work independently with little direction but also work cohesively with the team
Exceptional customer service in a fast pace environment
Ability to frequently walk, transport, bend and reach
Ability to frequently lift 5 - 50 lbs
Experience with Concur preferred
Experience with SharePoint preferred
Proficient in Microsoft Office, including Word, Excel, PowerPoint, Access, and Outlook
Bachelor’s degree or a combination of education and experience that yields the required knowledge, skills and abilities preferred

Associate Director Physician Early Clinical Development Resume Examples & Samples

PhD in scientific discipline
Extensive general medical knowledge
Experience in several organizations and geographic locations

Clinical Development Specialist Resume Examples & Samples

Providing case support for heart mapping systems
Responsible for setting and delivering territory targets
Visit and develop network with existing and potential customers
Work with Electrophysiologists, Cardiologists, Cardiac Technicians and decision makers in the medical community
Follow up tender processes for key accounts
Manage both direct sales and distributor sales activities all within the rules of healthcare Compliance
Education: University degree (Engineering, Chemistry, Biology, Biomedical, Biomedical Engineering)
Years of Experience:+ 4 years sales or +2 years clinical experience in Health Care Sector
Language: English
Location:Ankara
Relocation availability: YesSales

Clinical Development Specialist Resume Examples & Samples

University degree (Engineering, Chemistry, Biology, Biomedical, Biomedical Engineering)
4 years sales or 2 years clinical experience in Health Care Sector
Proficient user of English
Proven track record of achieving/exceeding sales objectives
Problem solving skillsSales

IT Digital Clinical Development Expert Resume Examples & Samples

Experience with agile/rapid prototypes, product
Experience with Apple ResearchKit is a plus
Project Management skills (Project Planning, Status reporting/tracking)
Fluency in English (written and spoken) is a must
Highly developed communication and inter-personal skills with the ability to influence and persuade through personal credibility, integrity and professionalism

Global Head of Clinical Development Resume Examples & Samples

To provide clinical and strategy leadership in cross-functional projects and product/project teams
Responsible for designing and executing clinical development plans across the global businesses
Leading a team of Medical Directors, based in various geographies
Responsibility for developing and maintaining the overall medical strategy of products in portfolio, for validating this strategy with appropriate internal or external experts and for agreeing the strategy with the appropriate internal business stakeholders
To be responsible that project activities and milestones are planned, agreed and achieved according to the overall clinical development plans (it includes pre and post marketing activities)
To be responsible for the timely and accurate completion of projects documentation such as protocols, amendments, case report forms and study reports
Verifies scientific accuracy of safety and efficacy summaries for regulatory/ commercial purposes and assists with the clinical sections of regulatory dossiers and or product specific scientific discussion, depending on pre or post-marketing activities
Collaborating with multiple functions to ensure patient safety, minimize risk, select products for development
Work with teams and outside experts to design clinical development plan and to support clinical research strategies for regulatory approval, reimbursement and adoption
To provide coaching and leadership to his/her team
Drive compliance/closure of Regulatory and Quality requirements before approving NPI program milestones
A minimum of 5 years Pharmaceutical, Biotech, Contract Research Organization or Medical Device industry experience
At least 5 years’ experience in GCP Clinical trials
Experience managing complex projects and/or across global regions desirable
Experience in managing team of senior professionals
Experience in interaction with FDA, EMA and/or other agencies
Good process knowledge, experience, and skills
Customer savvy and understanding of clinical and Industry environment
Post graduate training / specialization in one of the following areas is desirable: Neurology, Cardiology, Radiology, Nuclear Medicine or Oncology, with industry experience

Director of Clinical Development Resume Examples & Samples

Represents CD project teams for rare disease programs and addresses CD study or other program-specific questions, provides updates, delivers presentations and guides clinical decision making/ issue resolution
Maintains scientific and clinical knowledge in Alpha 1 Anti-trypsin Deficiency, Hereditary Angioedema and other specific therapeutic and disease area(s) of assignment
As appropriate, participates in ongoing enhancements and development of team processes, structures, and tools
Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as internal groups, including, research, CMC, operations, legal and business development
As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
Develops and provides input for clinical presentation slides and other materials for internal/ external meetings and ongoing communications
M.D. or Masters/Ph.D. in Biological Sciences, Pharmacology or a related scientific discipline
Emerging research experience in rare diseases and/or gene therapy

Clinical Development Specialist, MR Resume Examples & Samples

Evaluating performance and quality of features throughout the development process by designing protocols, traveling to partner sites for installation and testing
Supporting sites on the east coast along with facilitating evaluation of WIP packages in partnership with GEHC MR scientist
Assisting with customer complaints, investigations, and ultimately offer product solutions
Developing (clinical) competitive intelligence to support the field with counter arguments and selling advantages
Supporting scientific congresses, customer seminars and internal training events
Ensuring high quality MR training is delivered to the field applications teams and sales/marketing team
Certified Radiologic Technologist (ARRT) or global equivalent
Min. of 5 years’ experience in MR, including all clinical applications and performing procedures
Experience interacting with customers in various situations
Experience communicating scientific data (verbal and written)
Ability to present complex material to diverse audiences
Ability to work well independently and as part of a team
Creative, flexible and well organized
Must be willing to work out of the ASL lab at the New York
Ability to travel 10-20% of the time
Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables
Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Advanced degree (Bachelors or Masters)
At least 10 yrs. experience in the medical industry
Applications experience
X-ray, CT, or NM experience
Previous GE Healthcare experience
Familiarity with the relevant GE Healthcare MRI product range, and clinical optimization
Competitive experience

SVP Clinical Development Resume Examples & Samples

Provides overall strategy and direction of clinical trials, processes and procedures
Acts as a primary senior-level contact for customers
Provides scientific/regulatory oversight and project/therapeutic training to project teams
Interacts and collaborates with the Medical Writing department in the preparation of clinical development plans, protocols, investigator brochures, and medical/clinical reports, as required
Other tasks and duties as determined appropriate by Executive Management

SVP Clinical Development, General Medicine Resume Examples & Samples

Act as Scientific Director / consultant as required by the needs of the projects
Responsible for coordinating the acquisition of necessary medical/scientific input from outside experts/consultants/advisors
Represents the Company by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals
Participates in the development of Standard Operating Procedures (SOPs), medical/scientific tools, training, staffing requirements, etc
Interacts with senior management and contributes scientific/medical input to other departments, as appropriate
Ensures quality standards are set and maintained over all areas of responsibility

Associate Director of Clinical Development Resume Examples & Samples

Working in collaboration with the project(s) Clinical Lead and assigned Project Management staff, supports overall planning and implementation of assigned development program(s)
Interfaces with departmental staff to share scientific and clinical information and ensure implementation of consistent and best practices
Supports protocol review discussions concerning scientific and procedural aspects of study design, and integration into the overall program plan
Serves as resource for non-clinical research staff concerning program related questions and issues
Adheres to strict regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
Contributes to the development of study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed
Provides writing and review function for clinical aspects for regulatory documentation, INDs, IND annual reports, IND safety reports, Investigator Brochures, NDAs/MAAs, product labeling
May contribute to the design and development of Case Report Forms, Data Management Manuals and Data Analysis Plans, as required
Helps insure consistency across protocols. Presents scientific information if needed
May contribute to the preparation and/or review of data listings, summary tables, and study results
Writes and/or provides critical review for scientific presentations (abstracts, orals and posters) and manuscripts for publication
Determines the functions most critical to company success and supports priorities within functional area
Anticipates fairly complex obstacles and client difficulties and implements solutions that meet goals
Pharm.D or Ph.D. in a relevant field with 7-10 years related experience, with knowledge of clinical development and product registration, is preferred
Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies
Must be able to design and use all available vehicles for effective scientific communication within the company

Clinical Development Liaison Resume Examples & Samples

Assist in defining, developing, and implementing functional sourcing strategies determined by leadership
Work with Clinical Operations leadership team to manage vendor portfolio strategy
Establish and maintain effective Vendor Governance Committees to ensure clear communication pathway for assigned vendors and internal teams
Accountable for identification and management of opportunities and issues that arise with these accounts, and proactively prevents issues from occurring
Proactively manage ongoing relationships with key partners (e.g. monitors vendors using fact based assessment & metrics) to drive and develop industry’s best practice, innovation, quality, and inform future outsourcing decisions
Ensure cross-fertilization of vendor knowledge and best practices across operational groups, Partner vendors, and across industry
Represent gRED Clinical Operations in cross-functional or cross-business unit vendor forums
Effectively partner with other sourcing/vendor related functions, establishing and managing service level agreements and strategic and operational documents as appropriate
Provide operational input to the sponsor & vendor operational committees/teams as appropriate. Lead governance bodies, ensure regular governance meetings take place, and develop the agenda topics
Ensure that global Genentech / Roche relationships with vendors are leveraged and that potential conflict of interests/competition between early and late stage development, and between gRED and pRED are transparent and proactively addressed
Ensure partnerships are implemented according to ethical/regulatory/legal requirements. Partners with appropriate functions to ensure key management documents are in place (Master Services Agreement, Quality Agreements, etc.)

Clinical Development Tech Resume Examples & Samples

Assists content developers in the numbering of clinical notes, preparing PDFs for consultant review, compiling consultant feedback for consensus and data entry of finalized content into editing environments
Updates guideline detail screen dates in Q&A Editor
Prepares clinical content for coding, data entry of codes into editing environments, runs code reports from authoring tools, and provides QA of finalized coding deliverables
Collaborates with clinical staff and ClinOps with consultant recruitment by contacting potential recruits, tracking responses, and sending reminders. Assists in securing consultants for content review and validation
Provides QA and proofing of documents to ensure accuracy of final product deliverables
Supports administrative needs of clinical initiatives, including but not limited to case testing, searching and ordering articles for research. Provides data and analytical support to clinical staff
Minimum 2 years administrative experience required
Excellent organizational, communication, project management, and computer skills
Ability to multi-task to complete simultaneous projects

Senior Director PV Clinical Development Services Resume Examples & Samples

Responsible for global oversight for Regulatory compliance and management of safety CRO activities including resolution of PV queries for clinical studies and SAE reconciliation
Partner with key stakeholders within and outside PV to ensure continuous harmonised operations of global PV clinical activities to maintain high standards for functioning in an integrated environment
Define the standards and requirements per global regulations for reporting of clinical trial safety reports
Ensure oversight for investigator and CRO training
Ensure PV Clinical goals align with goals of the entire organization
Liaise with and advise clinical, BDM, QA, regulatory and other functional areas locally/globally on matters relating to pharmacovigilance to ensure overall compliance and appropriate standards and methodologies within the company
Address consistency in collection, processing and evaluation of safety data, development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements in Takeda global processes
Drive preparedness for regulatory authority inspection and internal audits for PV processes supporting clinical trial conduct. Serve as the primary functional interface from Pharmacovigilance for subject matter expertise on PV processes supporting clinical trial conduct content
Bachelor’s degree required. Advance degree preferred
Substantial pharmaceutical or health care related industry experience required
Must have significant PV experience including experience working with CROs, vendors, and relationship management
Experience in people management and well developed skills in teambuilding, motivating, empowering and developing people
Demonstrated skills in negotiation and consensus decision making
Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements
Excellent understanding of databases, coding and data mining methodologies
Critical thinking and analytical skills and ability to make high level decisions in cross-functional and global environments
Understanding of and contribution to Takeda business needs and global strategy
Able to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner
Multi-tasking with the ability to successfully manage multiple critical issues simultaneously

Clinical Development Consultant Resume Examples & Samples

Graduate of a four year BSN program; an Unrestricted US RN License
Overall work experience of 15 plus years in the US Healthcare Industry working for Health plans and Hospitals
10 plus years of most recent job experience in Care Management primarily in Utilization Management and/or Clinical Claims review functions
Prior experience with other related Health plan processes during the career is a plus ( Appeals, Compliance etc)
Strong expertise in clinical criteria (MCG or Interqual); Knowledge about NCQA, URAC, State and Federal guidelines as it relates to Utilization Management Operations
Managed care UM training experience, preferred
Well-developed written and oral communication skills with the ability to explain complex information clearly and convincingly
Broad knowledge of managed care and regulations
Demonstrated ability to coach, mentor and develop others
Strong leadership ability, proven skills in critical thinking and ability to pursue goals with tenacity and sense of urgency
Strong interpersonal skills to collaborate and effectively work through a complex organization to influence change
Proven supervisory experience leading small to medium sized teams
Preferably based in Cognizant’s delivery location in Phoenix or Tampa. Must be willing to travel internationally for extended periods of time. Domestic travel around 50% to client sites during other times

Global Head of Clinical Development Resume Examples & Samples

Lead clinical development across therapeutic areas
Manage the clinical development organization with high ethics and scientific acumen
Serve as clinical development expert and provide support and advice to the entire organization
Identify and implement high value strategies for product life cycle development and expansion across the entire NHSc portfolio
In conjunction with R&D Operations, implement strategies to enhance quality and efficiency in clinical studies
Communicate internally and externally clinical study outcomes, including scientific publications
Collaborate in translational research projects within Nestle Health Science and across Nestle research institutes
Maintain and develop collaborations and advisory relationships with experts in industry and academia
Participate in due diligence efforts
MD or DO degree with at least 8 years of direct pharmaceutical industry experience in clinical development
Relevant experience and robust track record in designing, managing, and analyzing clinical trials
Clinical experience and board certification/eligibility
Established network and track record of collaborations across industry and academia globally
Ability to travel globally (25% annually)
Fluent in English

Clinical Development Analyst Resume Examples & Samples

Spearheading special projects / process-improvement initiatives, including development and support of sophisticated models, standardized processes, tools, and/or training materials
Bachelor's Degree (Process Eng., Econ, Acct, Finance or Healthcare related preferred). GPA 3.5+ a plus
2-5 years of relevant experience. Healthcare, Pharma or consulting experience a plus. Chain- or multi-facility experience also a plus
Advanced Excel skills including mastery of all functions, formulas, ability to manipulate and analyze large data sets. Programming skills highly desirable
Proven PowerPoint skills, from visualizing to framing and creation of decks for executives
Tableau, Essbase, Oracle or other relational database experience a plus
Strong project management, planning, organizational, and process improvement skills
Good written and oral communications. Ability to summarize information and succinctly communicate analysis verbally and in writing. Ability to effectively present information and interact with senior management

Head, Clinical Development Standards Resume Examples & Samples

University/college degree is required
An advanced degree (e.g. Masters, MBA, MD, PhD) is preferred
12 years of experience in the Pharmaceutical Clinical Development industry is required
5+ years of experience in a senior managerial position leading people is required
Advanced expertise in CDISC, ADaM and SDTM standards is required
Advanced expertise in at least one of the disciplines of data management, statistical reporting and analysis is required
A thorough understanding of clinical research processes is required, with demonstrated expertise in deploying Clinical Development Standards supported by technology is required
Ability to thrive in a global multicultural matrix environment is required
Ability to manage high workload and critical issues in a timely manner is required
Knowledge of HL7 standards is preferred
This position requires up to 25% travel both domestic and international

Clinical Development Specialist, MR Resume Examples & Samples

Evaluate performance and quality of features throughout the development process by designing protocols, traveling to partner sites for installation and testing
Assist with customer complaints, investigations, and ultimately offer product solutions
Develop (clinical) competitive intelligence to support the field with counter arguments and selling advantages
Support scientific congresses, customer seminars and internal training events
Ensure high quality MR training is delivered to the field applications teams and sales/marketing team
Highly experienced in MR, including all clinical applications and performing procedures
At least 7 yrs. of experience in the medical industry
Customer contact experience in various situations
Teaching ability: present complex material while maintaining a professional image
Familiar with the relevant GE Healthcare MRI product range, and clinical optimization
Must be legally authorized to work in the United States full-time
Must be willing to work in our Waukesha, Wi facility full-time
Must be willing to take a drug test as part of the selection process
Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background
Application experience

Senior Director of Clinical Development Resume Examples & Samples

Knowledge in clinical research and drug development
Skills in management
Skills in strategy
Bachelor's Degree Required
10+ years of Management experience
10+ years of Oncology Research experience
Pharma/CRO Management experience

EP Clinical Development Manager Resume Examples & Samples

Strong knowledge of Electrophysiology with practical experience is a must
Strong clinical knowledge and understanding, strong knowledge of CARTO system and BW ablation portfolio (SmartTouch, nMARQ, others)
Bachelor's degree with at least three years of directly related experience including one year of leadership experience and strong coaching skills
High level of dependability, enthusiasm, honesty, positive and upbeat attitude
High level of initiative and self-motivation
Quick to learn along with a willingness to learn
Outstanding writing and verbal communication skills: fluent in English - knowledge of other European languages would be an asset
Strong operations and creative problem solving experience
Strong PC hardware and software troubleshooting skills

Clinical Development Coord Resume Examples & Samples

Accountable for coordination and supervision of clinical training, education, orientation and preceptors
In addition, they may participate in planning, implementing, coordinating and evaluating patient care activities, staff education, and management activities as delegated by the Clinic Manager or Clinical Services Leader
Work in partnership with site leadership. These synergistic relationships leverage strengths and expertise of all roles to support exceptional clinical quality results greater than could be achieved individually. This partnership will provide a unified perspective and voice to deliver on Our Commitment to Care standards and behaviors

Clinical Development Director, MLD Resume Examples & Samples

Medical degree with Board Certification/Specialty background, or equivalent status, in a relevant area (Pediatrics, Neurology, Transplantation or similar). Additional post-graduate research qualification (e.g., PhD) or research experience is an advantage
Previous experience of working in pharmaceutical product late stage clinical development. Although not obligatory, previous relevant experience of working in Rare Diseases or Cell or Gene Therapy will be highly advantageous
For UK candidates: Active GMC registration essential; Postgraduate qualification in Pharmaceutical Medicine is advantageous
A marketed portfolio in PAH (pulmonary arterial hypertension) with strong growth prospects and focus on patient support
Two development programmes in amyloidosis, a rare and fatal family of disorders: IONIS-TTRRx (GSK2998728) being developed in conjunction with Ionis Pharmaceuticals for transthyretin (TTR) amyloidosis, and anti-SAP, a combination of a small molecule and an anti-SAP monoclonal antibody that is applicable for all forms of systemic amyloidosis
As part of the Gene Therapy group - ex-vivo gene therapy being developed in conjunction with TIGET/Ospedale San Raffaele (OSR) in Milan, initially for ultra orphan monogenic diseases such as ADA-SCID (adenosine deaminase severe combined immune deficiency), WAS (Wiskott Aldrich Syndrome), MLD (Metachromatic Leukodystrophy), followed by Beta thalassaemia and other applications. Strimvelis gene therapy for ADA-SCID was approved in May 2016 via an MAA that supports patient access at the single site in Milan
Provide clinical leadership and disease area expertise in the design and conduct of late-stage clinical trials. The role requires

Senior Clinical Development Manager Resume Examples & Samples

BA/BS
5 years of drug development experience including clinical development experience
Oncology clinical development experience (early preferred)
Candidate will be able to assume direct responsibility for initiating, conducting, and reporting oncology clinical studies
Experience in developing and writing study protocols, study procedure manuals, informed consent forms, clinical study report, and manuscripts
Ability to work independently and proactively and to take on leadership roles on cross-functional study teams
Key skills include verbal and written communications, with the ability to present to internal department meetings and external advisory/investigator meetings
Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)
MS, PhD or PharmD, or higher education preferred
Previous experience in discovery and early phase programs including candidate selection preferred
Oncology clinical development experience across Phase I-IV
Proven track record of leading a clinical matrix team and working with investigators, external experts, Contract Research Organizations, Local Operating Companies, and vendors
Provide strategic leadership for the development of an asset or portfolio of assets, generally from candidate selection through commit to medicine development
Execute the broad strategy and vision of the organization through the leadership of a multi-disciplinary matrix team within the R&D organization
Help to define and mitigate key development risks of a compound
Work closely with functional lines to define the initial risk benefit of a compound, and continually evaluate and identify key clinical and pre-clinical data required for decisions around compound progression
Facilitator of decision-making both within the project team and with external stake-holders such as DPU-heads, SRB, PIB, GSB (coordinated with the clinical lead and GCSP), regional groups, and external advisors
Serve as a clinical and operational team leader on global and regional teams
Work and manage CRO partners
Create and foster strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring and pre-Clinical Development
Lead the design, implementation, operations/study management, and interpretation of clinical trials
Lead the writing of protocols, Informed Consent Forms, clinical study reports and regulatory-related documents
Support the writing of subsequent regulatory briefing documents
Lead and accountable for study start up activities, site initiation visits, interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings
Ensure trials are conducted effectively, reach target enrollment, and are conducted within budget- and time-constraints, in partnership with AROs/CROs and GSK regional and in-country groups, to deliver submission-quality data
Demonstrate efficiencies in the areas of budget management, contracting and resourcing
Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements
Work with external experts to develop abstracts, manuscripts, study/program design and presentations
Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions
Ability to directly manage line reports as well as serve as mentor and coach of colleagues
Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards
Proactively generate ideas for improvements and takes actions to solve problems and achieve goals beyond what is required

Early Clinical Development Program Manager Resume Examples & Samples

Clinical project management of an ED clinical program/study
Develop and manage study budget
Provide input on operational aspects of the protocol
Responsible for/contribute to vendor selection and ongoing management and oversight of all outsourced activities
Develop and manage Study Management Plan and all associated documents (i.e. vendor oversight plan)
Collaborate with vendors and internal stakeholders to ensure that data is available for review by the Safety Review Committee in a timely manner
Plan, facilitate and lead SET internal meetings as well as act as the CSL lead for vendor meetings
Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and internal stakeholders
Ensure Clinical Operations team and external partner receive study specific training
Facilitate study close out activities through completion of Clinical Study Report
A minimum 6+ years’ relevant clinical research (or related) experience within the pharmaceutical industry
Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. Negotiation and influential skills advantageous
Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data

Early Clinical Development Study Manager Resume Examples & Samples

Clinical project management of an ED clinical study
Collaborate with Clinical Supplies & Logistics team to plan and coordinate Investigational Medicinal Product (IMP) and non-IMP supplies
Ensure monitoring plan is developed and consistently executed in collaboration with appropriate stakeholders
Report key study performance information
Bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. Other degrees and certifications considered if commensurate with related clinical research experience
A minimum 4-6+ years’ relevant clinical research (or related) experience within the pharmaceutical industry
A solid understanding of the drug development process, and specifically, each step within the clinical trial process
Budget forecasting and management
Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process; maintain current medical/scientific/regulatory knowledge
Demonstrated ability to lead teams and work in a fast-paced team environment. Experienced in working within cross-functional team in a Matrix Environment
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs

Clinical Development Engineer Resume Examples & Samples

Apply in-depth knowledge of the operating room environment and of the da Vinci®Surgical System in order to become an expert within the company on the clinical application of Intuitive’s products
Collaborate closely with product management and product development to define and validate clinical performance goals for new products
Assess and document clinical risks, and advise engineering regarding risks and mitigations
Take an active role in new product development teams, including contributing to team meetings and design reviews, and providing design guidance to engineering design teams
Write protocols and conduct formal validation testing for new products, product updates and releases, and modifications to existing designs, in order to validate the clinical safety and efficacy of the product. Support FDA/regulatory documentation and applications
Perform informal assessments of the clinical performance of prototype designs
Work with product management and product marketing to conduct product-specific “focus group” meetings with key customers at scientific conferences and in house
Work with clinical sales representatives and surgeons to identify clinical needs and complementary devices in the marketplace
Identify potential product enhancements & new product ideas by applying an analytical approach to understanding the clinical needs of surgeons
Support and sometimes manage clinical evaluation of new or enhanced products at key customer sites
Maintain up-to-date knowledge of clinical applications of the da Vinci® Surgical System, and to transfer product knowledge to the customer interfacing groups as part of product and procedure launch activities
Collaborate with other organizations within the company as needed, including regulatory, human factors, training, and sales
Provide a clinical voice and evaluation to continuing engineering projects of the existing da Vinci® Surgical System platforms and EndoWrist® Instrumentation
Keep the organization’s vision and values at the forefront of decision making and action
Perform other duties as required to support the company's overall strategy and goals
B.S. in Mechanical Engineering, Biomedical Engineering or similar
Minimum of 3 years of experience in medical device industry required
Experience working with surgeons in an operating room environment
Fluent in surgical terminology and sound knowledge of anatomy and surgical technique
Excellent mechanical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products
Experience with design control (risk analysis, validation, verification, testing) preferred
Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to insure project success
Self-starter needing minimal supervision
Self-confident and able to react quickly under pressure
Excellent verbal and written communications skills required including presentation of technical content
Ability to travel up to 30% of the time, internationally and domestic

Global Early Clinical Development Lead Resume Examples & Samples

Be involved in a wide range of early R&D pipeline projects,
Provide leadership for first-in-human (FIH) study conduct and , when required, lead Early Clinical Development’s FIH Committee
Have a translational and methodologically-innovative mindset, knowledge of the application of biomarkers (and other experimental medicine methodologies) in early drug development projects
Be expected to undertake leadership of an early clinical development team, from a pre-FIH stage to POC
Proven ability to meet the clinical requirements set out in Responsibilities above
Functional managerial or leadership experience
Laboratory research methods

Summer Internship Clinical Development Operations Resume Examples & Samples

Work with various members of the Clinical Development Operations team on a variety of tasks to support the execution of clinical trials
Must be in the process of earning a Bachelor’s or graduate degree
Must have completed at least two full years of study
Ability to work effectively in a team environment with all levels of personnel
Proficient in Microsoft Office (Excel, PowerPoint, Word)
Ability to prioritize and handle multiple projects with competing deadlines
Coursework in life sciences or business

Clinical Development Manager Resume Examples & Samples

BA/BS in Life Sciences
MS, PhD or PharmD
Infectious diseases development experience across Phase II-IV
Provides leadership to large, matrix regional operations team, with accountability for study execution, tracking and management of study delivery
The Clinical Development Manager will be able to assume direct responsibility for initiating and conducting clinical studies in the infectious diseases therapeutic area
Make decisions which balance risk/benefit with clear understanding of impact on project; takes action to mitigate risk where appropriate. Develops and monitors progress against recruitment plan, manages risk, implements contingencies as required
Drive assessment, selection, contracting, training and management of appropriate vendors for outsourced clinical activities/services, ensuring appropriate oversight and compliance with GSK standards
Develops and maintains the global study budget, ensuring cost effectiveness and addressing and escalating issues as appropriate
Ensures set up and maintenance of all systems in order to plan and implement the study and track progress. Ensure streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data
Ensures appropriate clinical trial supply strategy is implemented and managed
Accountable for timely delivery of scientifically and operationally robust study documents
In partnership with the clinical study team, develops a focused study protocol that meets scientific objectives and can be implemented in the clinical and regulatory environment of all participating regions to provide quality data and ensure timely study delivery
Ensures accurate maintenance and archiving of study records
Ensures global feasibility of contractual agreements
Accountable for site and monitor training in operational aspects of the study
Develops and implements study communication plan to ensure efficient and appropriate global communication to all internal and external stakeholders. Accountable for resolution or escalation of operational issues
Leads ‘After Action’ reviews to capture and shares best practices
Lead and drive significant cross-therapeutic/functional business change initiatives according to company and/or group strategy and business needs. Be accountable for implementing new business processes and strategies; may also proactively identify issues, and propose strategies to manage implications and risks on clinical study/studies timelines, budgets and goals

Associate Director, Lean Clinical Development Resume Examples & Samples

Lead all aspects of the Enabling Business Information Solutions (EBIS) out of pocket and project spend life-cycle, including budgeting, forecasting, analyzing and reporting to actuals on a monthly basis and in alignment with annual business plan updates
Develop the project budget based on various assumptions and scenarios
Forecast project spend based on various assumptions and scenarios
Track actual spend versus forecast and variance analysis reporting
Build and maintain relationships with key Business Partners, including Finance and Project teams to achieve successful collaboration in order to identify areas where financial performance is not on plan and analyze performance for causes and areas to change and improve performance
Continuously improve the structure, process, analytical methodologies and/or communication tools in support of optimal financial planning, tracking and reporting for EBIS projects
Develop processes and tools for measuring and quantifying project savings and Return on Investment (ROI). Monitor, analyze and report to Senior Management regular, detailed reviews of project savings relative to projections
Design and implement process improvements for budgeting and financial performance metrics related to projects
Address challenges with respect to applying Lean concepts to the clinical development environment
Provide Lean/Six Sigma expertise to project teams in Global Clinical Development Operations (GCDO), as well as Lean Process Mapping
Develop the Lean roadmap, schedule and deployment plans, including the tactical projects to be executed, their scope, deliverables and ROI
Participate in the improvement project prioritization within and across functions, and develop appropriate metrics and measures to assess business benefit of improvement activities
Contribute to the development of what constitutes Lean and a Lean culture in GCDO
A minimum of a Bachelor’s Degree in Business, Engineering, Science or a related discipline is required. Master’s Degree preferred
A minimum of 8 years of relevant experience in the Pharmaceutical industry (i.e. Research & Development, drug development, operations, and/or financial/budget management) is required
A minimum of 4 years of experience working in matrix organization with cross-functional teams is required
Finance and/or Accounting experience is required
Proven track record in delivering transformational process improvement implementations yielding a positive ROI for organizations is required
Knowledge of Process Excellence (Lean, Six Sigma) tools and methodologies required
Lean/Six Sigma Green or Black Belt Certification or willing to obtain a Lean/Six Sigma Certification once in this role is required
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is required
Advanced knowledge of MS Excel (Formulas, Pivot Tables, VLOOKUP, Statistical Analysis) is required
Experience with information systems (e.g. SAP, Clinical Trial Management Systems, Planning Systems, Procurement Systems) and financial aspects of conducting clinical trials is preferred
Experience with Project Management and Project Management software (i.e. MS Project, PMX) is preferred
Experience with Planisware, Cognos, Beacon, Medidata and Tableau preferred
Must have excellent written and verbal communication skills and strong presentation and analytical skills
Must be excellent planning and tracking skills
Must be results-oriented with the ability to handle multiple projects simultaneously and respond to changing needs of the business
Global experience and the ability to work virtually with business partners required
This position will require up to 10% domestic and international travel.Clinical Data Management

IT Business Partner, Clinical Development Resume Examples & Samples

Accountable for positioning Clinical Development for success in the digital era: lead and accelerate Clinical Development’s digitization through technology innovation, ensure that Clinical Development’s information capabilities and operations are reliable, accessible and secure, and enable Clinical Development’s transformation to become competitively differentiated in a rapidly-changing scientific landscape
Responsible for identifying digital capabilities that have the greatest impact on R&D Clinical Development, set the right expectations, and ensure that IT delivery resources are appropriately engaged to fulfill the business outcomes. Develops strategic roadmap(s) describing a vision for the long-term development of Clinical Development IT digital capabilities, and translates those roadmaps into actionable capability projects with clearly articulated business cases
Responsible for developing strategic and collaborative partnerships with senior Clinical Development leaders. Trusted partner to Clinical Development leadership, and works closely with them to ensure that IT fully supports Clinical Development’s scientific mission
Partners very closely with adjacent IT teams supporting clinical operations, translational medicine, biostatistics, regulatory and medical to ensure that digital capabilities supporting the specialist scientific needs of clinical development leadership are identified and addressed
Matrix leadership of IT resources in other IT functions: responsible for ensuring that all IT functions are successful in their delivery of services to Clinical Development. Key matrix IT partner functions include platform architecture, software engineering, application support & maintenance, program management, information & data management, collaboration services, infrastructure services
Strong domain expertise in the application of IT to Clinical Development, including a broad understanding of clinical research processes and how they are supported by IT tools and systems
Experience of large-scale clinical data integration and analytics, and knowledge of current techniques and challenges in this space
Ability to lead the analysis of complex and ambiguous clinical science needs, and integrate those into compelling and actionable strategic plans
Excellent collaboration and communication skills, with the confidence to build strong partnerships with senior scientists and executive-level physicians
Excellent skills working within the IT matrix to define and deliver specialist digital capabilities
Track record of delivering high-value data integration capability projects in a clinical research environment
Experience working with other data types beyond RCT data, eg genomics, real-world data types (EMR, prescriptions, health outcomes data etc)
Background in clinical sciences or clinical biostatistics
PhD/ MS in Life Sciences, Biostatistics or a related discipline
10+ years experience in leadership roles in IT for biopharma R&D, clinical science, bioinformatics, biostatistics, and/or translational research in industry or in academia

Clinical Development Lead-immuno Oncology Resume Examples & Samples

7-10+ years’ pharmaceutical or relevant medical/clinical experience
Keen understanding of drug development
Experience with clinical and translational investigation of cancer immunotherapies is a plus
Demonstrated track record of successfully developing and executing Clinical Development Plans
Proven ability to strategize, prioritize, and manage multiple projects simultaneously to ensure quality, timely, on-target and within budget accomplishment of tasks
Ability to embed medical functional skills and strategic thinking into teams

Head of Clinical Development Isatuximab Alternative Malignancies Resume Examples & Samples

Propose signal finding / POC studies which inform Go/No go decisions to indication enabling clinical development paths that fulfil unmet needs
Oversee the development of study concepts, ES and protocols in collaboration with the Isatuximab Core Team. Cooperate with Medical Operations and the CSO in the development of other necessary documents for clinical studies, providing expert medical input throughout
Act as the medical expert in the design and implementation of clinical development strategies and global clinical development plans, acting as the key driver in transversal organizational implementation
Represent medical expertise for regulatory interactions, investigators’ and expert advisory board meetings, external professional societies, seminars, and conventions
Provide expert input in response to questions posed by health authorities worldwide
Write and/or review clinical sections of clinical/statistical reports, including investigator’s brochures, INDs, BLA, NDA, and other regulatory submissions
Communicate internally and externally on clinical trial designs and results
Minimum of 3 year experience in clinical research and development in the biotech or pharmaceutical industry
Experience in oncology development is required, specifically solid malignancies
Track record of leadership and strong communication skills
Experience working in matrix environment, ability to integrate all aspects of the projects and their potential impact on the clinical strategy, ability to propose new applications to support product and / or business expansion, ability to develop strong networks internally and externally beyond initial field of expertise
Experience in alliance partnerships or co-development, influencing and good communication skills
Strong medical background with good understanding of drug development process and experience with US and EU regulatory submissions
Strong demonstrated leadership and clinical expertise in field for effective international collaboration with external and internal stakeholders
Strong interpersonal and cross cultural communication skills for bridging between clinical and business or regulatory participants and take account of marketing, payer and regulatory needs
Experience managing high performing direct reports
Organizational awareness
Ability to access key competencies within the company and via an external network

Clinical Development Director Resume Examples & Samples

Medical expertise or recent experience within Immunology, Rheumatology or Nephrology
A postgraduate qualification (PhD) within a relevant area such as Immunology, Rheumatology or Nephrology
Experience of performing the role of a Medical Monitor, Safety Physician or Clinical Research Physician for clinical research studies
Clinical leadership and disease area expertise in the conduct of SLE or other autoimmune disease indication studies for Benlysta
Single point of accountability for the Medical Governance of the clinical trial with a global viewpoint of safety and efficacy
Physician leadership of the study team
Input to trial design, protocol development and medical aspects of the study conduct
Medical monitoring of the trial to ensure subject safety and appropriate detection and management of safety related issues
Active contribution to Safety Review Team and Clinical Matrix Team
Medical point of contact on behalf of GSK (sponsor) for external vendors, GSK Local Operating Companies, investigators and regulatory agencies

Global Clinical Development Operations Program Leader Resume Examples & Samples

Single point of accountability for providing strategic operational input to the clinical development plan, building the strategic operational plan and budget for GCDO deliverables and milestones, and provide global leadership to the execution to plan and/or define risk mitigation strategies and ensures implementation within GCDO thereof
Provides direct supervision and people management responsibility for all GTL staff within his/her group
Creates and gains endorsement of the global strategic operational plan (IDP/program level), inclusive of the sourcing strategy, supplier selection strategy, an aligned country selection plan and ensures an integrated data plan for external data streams is available and endorsed
Oversees clinical trial budget forecasting and management inclusive of OOP and FTE estimates
Leads CRO selection, ensures scope of work is defined and is responsible to define deliverables, turnaround times, and quality and performance levels for new sourcing needs
A minimum of a Bachelor’s degree in a scientific discipline is required
An advanced degree (e.g., Masters, MBA, MD, PhD) is preferred
Minimum of 10 or more years of experience in clinical development, with Leadership Competencies, along with a proven track record of global clinical operational experience (Phase 1-3B) or strong clinical project management experience in biotech, pharma or CRO environment is required
Excellent people leadership skills in a matrix environment is required, people management experience is strongly preferred
Profound experience in managing external stakeholders/CROs programs is required
Solid knowledge of global regulatory, quality and logistical aspects of global and local clinical trial conduct and oversight is required
Proven experience in leading a global R&D registration program is required
Early development / clinical pharmacology experience is required
Sound clinical financial acumen; experience with managing budgets is required
CRO management experience is preferred
Trusted, inclusive, leader with demonstrated experience in managing and mentoring global, cross functional matrix teams and a proven ability to foster team productivity and cohesiveness is required
Ability to provide strategic leadership, proven decision making skills, strong negotiating and conflict resolution skills is required
Willingness and ability to travel up to 15-20% of the time, defined by business needs is required

Clinical Development Director Resume Examples & Samples

4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s) with appropriate oversight from Medical Lead
7) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
8) As a clinical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
9) May work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed

Senior Manager, MR Clinical Development Resume Examples & Samples

Lead the development and deployment of standardized Application Services in the clinical applications domain (Standards / tools, Education materials and Best practices for both the field team and the customer)
Lead the development and deployment of competency management for all MR apps resources (Customer interaction, Problem solving, Clinical and Technical)
Actively funnel customer feedback to the BIU teams and Service to improve workflow/product and protocols
Strengthen Philips MRI brand by a continuous flow of locally relevant improvements and innovations (clinical standard and software improvements)
Lead the development and delivery of technical and clinical content in support of the strategic NA MR Brand direction
Foster the clinical science relationships with top tier customers in the market (Reference sites, Key Opinion Leaders, etc.)
Define and develop vision, mission and strategy goals for clinical applications, in a quickly changing customer environment
Lead a team of National Clinical Service Specialists and installed base engineers (functional only)
Define, develop and deploy Clinical Services in the clinical applications domain including
Master’s degree or equivalent combination of education and experience
Minimum 10 years of progressive experience leading MRI improvements within a clinical, operations, business or technology development environment
Minimum 5 years of leading a team of technical/clinical MRI experts
Direct customer relationship experience
Proven ability to influence and drive change through exceptional written and verbal communication skills
Demonstrated ability to challenge status quo, drive constant improvement, and ability to achieve organizational goals
Demonstrated experience leading and inspiring a team, managing customer relationships and/or managing a P&L or comparable
Proven change management experience
Program management experience
Proficient computer and Microsoft Office skills

Senior Mgr Clinical Development Operations Resume Examples & Samples

Partner to maintain appropriate resource levels and manage within budget
Supporting local and global process improvement initiatives
Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and local regulations
Maintain relevant therapeutic knowledge and clinical research best practices
Participate in external industry activities (eg. pharma associations, regulatory agencies)
BA/BSc/RN
Work experience in life sciences or medically related field, including biopharma clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharma or CRO company)
Previous management experience of direct reports including management level staff
MD/PHd/DO/PharmD/Master's Degree
Experience at or oversight of clinical research vendors (CRO's, central labs, imaging vendors, etc.)
Country clinical operations experience and/or regional study management experience
Advanced knowledge of global clinical trial management
Clinical trial processes and operations
Extensive knowledge of ICH/GCP, local regulations, clinical trial environment, requirements and guidelines
Project and program management experience including oversight of quality, study deliverables, budgets and timelines
Various TA knowledge
Clinical trial management systems experience and reporting tools
Eligibility to work in Hong Kong

Clinical Development Engineer Resume Examples & Samples

Minimum of B.S. in Mechanical Engineering, Biomedical Engineering or related field
Minimum of 3 years of experience in medical device industry
Excellent teamwork skills and willingness to cultivate collaboration across multiple disciplines
A willingness to learn new things across a broad range of disciplines
A willingness to pursue continuous improvement in all areas
Excellent analytical capability and practical skills to develop and test a thesis and draw succinct conclusions
Mechanical aptitude, intuition for spatial relations and the ability to predict the performance of a novel mechanisms
Sound knowledge of anatomy and clinical language
Effective communication skills (verbal, written, presentation)
Ability to travel up to 40% of the time, internationally and domestic
Experience working with surgeons in an operating room environment a big plus
Interest and experience in CAD, 3D printing, hands on prototyping a big plus

Clinical Development & Operations Manager Resume Examples & Samples

BSc. degree in Life Sciences, Public Health or other related discipline with clinical development experience
A background in clinical development sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience
Track record of global study/program management planning & delivery
Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional teams
Demonstrated ability to plan, organize and manage resources across a matrix organization to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics
Ability to establish and build internal and external relationships in a highly dynamic environment
Well developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
Proven expertise in the proactive identification of issues which may impact clinical studies coupled with the ability to contribute to solutions affecting cross-functional matrix teams
Demonstrated study leadership skills
Strong scientific/therapeutic expertise in Respiratory preferred
This role would also be suitable for an experienced Lead CRA looking to take the next step in their career in an above country role.”
Provides operational leadership to study teams, with accountability for study execution, tracking and management of study delivery
Ensure compliance with ICH/GCP guidelines, all applicable local laws and regulations, and GSK SOPs, for all products and services delivered for designated studies
Make decisions which balance risk/benefit with clear understanding of impact on the study; takes action to mitigate risk where appropriate. Develops and monitors progress against recruitment plan, manages risk, implements contingencies as required
Drive assessment, selection, engagement, training and management and oversight of appropriate vendors for outsourced clinical activities/services, ensuring compliance with GSK standards
Manages feasibility and determines global study allocation to appropriate countries and sites, ensuring efficient use of resources and adherence to company policies and strategic initiatives
Ensures set up and maintenance of all systems in order to plan and implement the study and track progress. Ensure streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data. Facilitate and support the business management monitoring of the these processes
In partnership with other members of the clinical study team, develops a focused study protocol that meets scientific objectives and can be implemented in the clinical and regulatory environment of all participating regions to provide quality data and ensure timely study delivery
Provides support to the Study Accountable Person (SAP) as appropriate to ensure the accurate and complete compilation, maintenance and archiving of study records e.g. trial master file (TMF)
Ensures continuous direct contact with in-country personnel to provide ongoing operational support
In partnership with the Study Accountable Person (SAP), leads ‘After Action’ reviews to capture and shares best practices
Support the implementation of cross-therapeutic/functional business change initiatives according to company and/or group strategy and business needs. Be accountable for implementing new business processes and strategies in studies (as appropriate); may also proactively identify issues, and propose strategies to manage implications and risks on clinical study/studies timelines, budgets and goals
Active partnership building for assigned studies and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills

Clinical Development Specialist Resume Examples & Samples

Introduce pre-operative clinical protocol to interested premium IOL accounts via initial services
Attend surgery to train surgeon and verify proper surgical technique of our premium IOLs
Attend critical post ops and educate patients to establish optimal outcomes with our premium IOLs
Use marketing tools/Panorama in the practice setting to integrate premium IOL usage, adopt best practices and maximize customer experience
Assist surgeons and staff with premium IOL verifications using our B+L IDVS portal
Secure & grow premium IOL business by working closely with B+L team members
Strategically assist the sales force to grow entire B+L portfolio
Understand key business drivers; use sales analytics and sales reporting to monitor surgeon usage in territory
Provide assistance for B+L customers via telephone and email
Build confidence and credibility around our people and our products
Stay current with industry knowledge and participate in B+L team calls
Preferred three years of experience in pre-operative measurements (keratometry, corneal topography, and axial length measurement), IOL power calculations, cataract surgery and post-op care
Preferred three years of experience in an ophthalmic industry setting with an emphasis on clinical work related to cataract and/or corneal refractive surgery

Exec Dir, Clinical Development Resume Examples & Samples

As the Clinical Lead, the Executive Director will be the Clinical representative on the Global Project Team and leader of the cross-functional Clinical sub team. S/he will be accountable for the development and execution of the global clinical development plan, working in collaboration with the members of the Clinical sub team
As the Clinical Scientist, will serve as a member of the Clinical sub team and have responsibility for providing scientific and clinical development guidance, as well as guiding other sub team leads, at the global product, project and study level
May perform the role of Global Project Team Lead and guide other sub team leads where s/he is responsible for the leadership of a cross-functional global project development team on one or more projects
Will represent R&D at regulatory agency meetings, symposia and trade associations and aim to establish and maintain a strong network within the Pharmaceutical industry
Will be expected to perform all the roles described as needed by the organization. Other activities, special projects and assignments may at times be expected
Dermatology Rx as well as device experience (e.g. implants/fillers) strongly preferred
5+ years’ experience as a cross-functional team leader

Intern, Clinical Development Resume Examples & Samples

Assist with data review for ongoing study (safety findings)
Create a list of all completed POAF trials with outcomes
Create slide repository from all POAF slide decks
Primary literature research – sympathetic/parasympathetic nervous system
Create list of replacement trials with outcomes
Create slide repository from slide decks
Diligence activities (literature searches, summarize articles, assist with slide development)

Intern, Clinical Development Resume Examples & Samples

Assist with data review for ongoing studies
BOTOX Pediatric Studies
LiRis Study 001
Assist team with study start up activities for the BOTOX Instillation Study, eg pharmacy manual, investigator meeting materials, etc
Other clinical research tasks identified in the department as they arise

Dir, Clinical Development Gi-ibd Resume Examples & Samples

The Director is the internal scientific expert in the disease area and scientific aspects of the competitive landscape and is accountable for ensuring the medical/scientific expertise, validity and integrity of the clinical development program and study protocols, clinical study reports and clinical and regulatory documents
Depending on the role, s/he leads or supports clinical study planning and execution through the development starting with the creation of the Clinical Development Plan (CDP) and clinical study protocol synopsis, input into the clinical study protocol and Clinical Study Report and Clinical sections of the CTD for regulatory submissions, while working collaboratively with the cross-functional Clinical Team to assess study data, integrate summaries of safety and efficacy, risk / benefit assessments, etc. This information is incorporated into Agency briefing packages, Investigator Brochures, and regulatory documents, including the clinical modules for submissions
In addition, the Director is a key contact for relationships to external experts / key opinion leaders and provides regular scientific-medical disease state updates, etc
The Director will work collaboratively with the Clinical Subteam Lead to ensure the development and execution of the clinical strategy. This includes the clinical team’s creation of relevant documents and outputs including Clinical Development Plan (CDP), clinical program feasibility, investigator’s brochure, study protocol synopsis, clinical study protocols, top line study data communication plan, Clinical Study Report (CSR), clinical sections of regulatory documents including the clinical sections of the CTD for regulatory submissions, and planning of the Annual reports together with Regulatory affairs and respective clinical team members. S/he ensures alignment of the CDP with the Global Development Strategy (GDS). In addition, working collaboratively with the Clinical Subteam Lead, the Director may monitor activities related to the Clinical development program, including achievement of key program milestones within the planned time lines and budget
The Director may also serve as a Submission team leader or co-leader for regulatory submissions
In collaboration with the core project team members and the departments involved, the Director leads the synthesis of the project development strategy, contingency plans, tactics, budgets, timelines, milestones and submission targets into the Global Development Plan (GDP)
The Director is responsible for adherence to all relevant regulations eg: ICH, PhRMA and CFR guidelines, as well as Allergan’s policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks. Support and oversight of epidemiological studies as needed. May provide strategic and/or technical consultations on behalf of the therapeutic area (e.g., study design, business development, marketing, communications, training, legal, etc.)
Therapeutic Area experience in GI strongly preferred
Uses facts and data to validate own position
Actively seeks to understand other perspectives
Articulates business impact
Actively influences others without a direct reporting relationship
Seeks more knowledge of industry, competitors
Execution and Accountability
Identifies and resolves complex problems
Takes charge of removing obstacles to project
Evaluates resource needs
Creates and communicates solutions for unpopular business needs
Global Mind Set
Demonstrates basic understanding of global environment
Build relationships with global colleagues
Demonstrates understanding and respect for cultural differences and needs

Clinical Development GI Diabetic Gastroparesis Resume Examples & Samples

Takes initiative to contribute ideas and knowledge to team globally
Participates in team activities
Actively listens
Adapts to change in team strategy
Influential Communication
Influences through reason
Matches communication to audience
Builds consensus
Communicates effectively with internal/external stakeholders
Encourages ideas from others
Explains complex issues
Make connections between organization, team, product, ideas, etc
Demonstrates some understanding of implications of strategic decisions
Welcomes change
Delegates to team and keeps them focused
Identifies and implements best practices
Identifies and drives priorities
Meets corporate timelines
Inclusive in interaction with others
Embraces diversity of thoughts, ideas, and approaches

Clinical Development Consultant Resume Examples & Samples

External Influence: Influence and challenge internal and external environmental factors that impact clinical research strategy
Bachelor’s degree in a scientific field or health-related field with no less than 3 years experience in Clinical Trials/Development
Good working knowledge of Good Clinical Practice
Demonstration of leadership behaviors; ability to work cross-culturally, accept challenges and seek opportunities to remove barriers, lead decisively in the midst of ambiguity
Therapeutic expertise and knowledge of the internal portfolio for the targeted therapeutic area
Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as neede
Demonstrated proactive problem solving through assessment and innovative, pragmatic solutions
Demonstration of strong communication skills (written and verbal); ability to break down complexity into clear and concise messaging
Experience in professional networking/customer service with positive mutually beneficial outcomes
Post-graduate degree recommended in some geographies

Early Clinical Development Senior Resume Examples & Samples

Create and drive study level timeline
Develop overall feasibility concept and enrolment plan with appropriate input from internal stakeholders
Ensure regulatory compliance and Good Clinical Practice GCP compliance
Responsible for oversight of Trial Master File TMF with periodic audits
Responsible for/contribute to vendor selection and ongoing management (including issue escalation) and oversight of all outsourced activities
Collaborate with Clinical Supplies &Logistics team to plan and coordinate Investigational Medicinal Product (IMP) and non-IMP supplies

Non-clinical Development, Toxicology Resume Examples & Samples

Searches literature, regulatory documents and Celgene internal database for targeted information
Collect appropriate data and collate them to document industry practice for regulatory submission e.g. overall genotoxicity assessment of approved small molecule drugs to treat advanced cancer patients
Help NCD Toxicology personnel to prepare focused scientific document
Under supervision, create and collate a digital image-bank using pathology reports, existent databases and archival slide requests. This project will require training and supervision in the use of digital slide scanning equipment, software and database maintenance
Basic understanding of biology/pharmacology essential
Knowledge of toxicology desirable
Basic literature search skills
Understand and follow protocols
Data collection and collation
Basic computer skills (knowledge of database software, excel etc) preferable

Clinical Development Eng-clinical Dev Resume Examples & Samples

Work closely with engineers and application specialists in the field
Embed clinical application in the field and support key customers
Lead and support research activities
Work closely with the marketing force to generate clinical evidence
Bachelor's Degree in Biomedical Engineering, Computer Science, Physics or closely related field
Experience as an engineer or scientist within the field of medical or bio-medical devices .(at least 3 years)
Strong understanding of physics and modality imaging fundamentals
Excellent communication (oral and written), influencing skills and ability to gain buy-in for initiatives
External focus. Understands the customer and market and is able to translate the opportunities into concrete actions
Experience in advanced applications, user-interface design and/or systems engineering
Team leadership experience
MD or Master’s Degree in Biomedical Engineering or related field
Demonstrated record of innovation in development
Experienced in Medical Imaging
Demonstrated ability to work in a collaborative, matrixed, and customer focused environment. Ability to work in groups or individually, as per the requirement of the project under consideration

Clinical Development Manager Resume Examples & Samples

Broad understanding of the pharmaceutical industry and the clinical development process
In depth knowledge of study management and data management and knowledge of essential regulatory guidelines worldwide and GSK company policies
Experience authoring high quality clinical protocols and reports (or equivalent types of documents)
Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams
Demonstrated effective oversight of outsourced activities
Excellent influencing and negotiation skills
Be responsible for the delivery and quality of all clinical studies from protocol concept to execution to final study report and for the validity of all data originating from studies
Be responsible for reviewing and/or enhancing the technical and scientific robustness of clinical plans and studies developed by the key customers for their designated area, while inputting and influencing
Lead operational excellence and data quality focus negotiations with vendors and strategic partners
Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies
Make decisions which balance risk/benefit with clear understanding of impact on project; takes action to mitigate risk where appropriate
Be accountable for a number of studies at any point in time
Develop and maintain the global study budget
Ensure set up and maintenance of all systems in order to plan and implement the study and track progress
Ensure appropriate clinical trial supply strategy is implemented and managed
Ensure efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data
Ensure adherence to Good Clinical Practice and all applicable local and international regulations
Be accountable for timely delivery of scientifically and operationally robust study documents
Lead a cross functional study team to author a focused study protocol that meets scientific objectives and can be implemented in the clinic to provide quality data and ensure timely study delivery
Lead development, review, finalisation and delivery of high quality key clinical study documents (including final Clinical Study Reports) in order to meet study timelines
Ensure accurate maintenance and archiving of study records
Be accountable for clinical vendor selection and contractual agreements
Drive assessment, selection, engagement, training and management of appropriate vendors for outsourced clinical activities/services, ensuring compliance with GSK standards
Be accountable for site and monitor training in operational aspects of the study
Ensure monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented
Be accountable for study related communications and for resolution or escalation of operational issues
Develop study communication plan to ensure efficient and appropriate global communication to all internal and external stakeholders
Ensure processes are in place to address or escalate study issues as they arise

Associate VP Non-clinical Development Resume Examples & Samples

Responsible for overall direction for toxicology, anatomic and clinical pathology serving drug discovery and development and for developing and implementing standards for the practice of nonclinical safety assessment in Allergan. Incumbent is also recognized in the toxicology/pathology community outside of Allergan and has participated in the formulation of best practices for the field. The incumbent ensures that the extent of nonclinical toxicopathology evaluations meet or exceed international regulatory requirements and their timely implementation through in-house or Contract Research Organizations (CROs) in full compliance with GLP regulations
Directly supervises and develops toxicologists, pathologists and other professionals to ensure functional and impactful representation on sub-teams involved in drug development and issue management. Contributes to world-wide IND/NDA/CTD and PLA summaries for regulatory submissions and provides technical response to inquiries related to nonclinical findings and interpretations. Provides technical review support for potential in-licensing opportunities
Act as an active member on the department leadership team. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures

EP Clinical Development Specialist Resume Examples & Samples

Acts as the area’s senior most clinical EP resource, responsible for developing talent in EP clinical competence and leadership across both clinical and sales teams
Demonstrates a thorough command of all EP capital and disposable products, including the EnSite System related product and technical knowledge, cardiac mapping and ablation techniques, trends, and competitive technologies
Provides insight, guidance, and feedback to management on market feedback and components of next generation of products
Provides additional back-up support to EP Sales Representatives in the following areas
Sales support
Customized Education Visits/Physician Feedback Sessions in regional training centers
Regional training seminars
Clinical studies/data collection
Trouble Shooting
New product in-service training to physicians, nurses and sales representatives
Mentors and provides leadership to EP clinical support teams including FCEs and EP TSSs
Continuously develops engineering, sales and technical skills relative to the overall Arrhythmia Management strategy, including learning opportunities via Sr. Sales personnel and FCEs
Partners with marketing organization to develop marketing data and resources to be used for employee and customer education
Performs related functions and responsibilities, on occasion, as assigned

Clinical Development Intern Resume Examples & Samples

Partner with physicians to analyze patient CTs
Support the Clinical Development team with Design Validation data collection and testing
Summarize and present clinical findings
Currently pursuing a Bachelor’s degree in Engineering or related field, such as Mechanical, Manufacturing, or Biomedical Engineering
Highly self-motivated and technically competent
Excellent verbal and written communication skills with attention to detail
Ability to work well both independently and as a member of a team is essential
Strong analytical and problem solving skills are preferred
Currently enrolled as a student for the duration of the internship project. Graduating August 2017 or later with a Bachelor’s or Master’s degree
Available for full-time for the duration of the summer. Specific dates flexible depending on school schedule
Strong interest in pursuing relevant industry experience within the healthcare and medical devices industry a plus
Must be legally authorized to work in the U.S

Exec Dir Oncology, Clinical Development Resume Examples & Samples

Provides oversight for all assigned Oncology projects to ensure study launch, conduct and closeout occurs according to the Customer’s and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations
Works with senior management and Business Development to set strategic direction for Oncology to better target types of projects across selected customer segments, makes recommendations, and drives strategy execution for successful business growth
Evaluates progress of Oncology projects and assigned staff to ensure the meeting of targets for utilization, realization, and timelines
As necessary, troubleshoots difficulties which may arise in project conduct between the company and Customer, and/or between Clinical Development. Facilitates team building and communication. Acts as a liaison and facilitator between other functional areas for overall operational issues

Exec Dir Ophthalmology, Clinical Development Resume Examples & Samples

Provides oversight for all assigned Ophthalmology projects to ensure study launch, conduct and closeout occurs according to the Customer’s and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations
Works with senior management and Business Development to set strategic direction for Ophthalmology to better target types of projects across selected customer segments, makes recommendations, and drives strategy execution for successful business growth
Evaluates progress of Ophthalmology projects and assigned staff to ensure the meeting of targets for utilization, realization, and timelines

Clinical Development Medical Director Resume Examples & Samples

4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
5) May be the Program Manager of other associates (e.g.., CSE)
6) May act as study medical monitor
8) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
9) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
10) May work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
11) Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support
12) Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
13) May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

Clinical Development Medical Director Resume Examples & Samples

5) May be the Program Manager of other associates (e.g., CSE)
≥ 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV
≥ 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
People management experience preferred, this may include management in a matrix environment. Global people management experience desirable

Director of Clinical Development Resume Examples & Samples

Will establish and drive teams to execute the strategic long-term vision for key pipeline drug candidate(s)
Develop and maintain clinical protocols and amendments, investigator brochures, and clinical study reports
Contribute to the strategic development of early to late stage clinical programs
Responsible for clinical development project teams for rare disease programs
Addresses CD study or other program-specific questions, provides updates, delivers presentations and guides clinical decision making/ issue resolution
Assist in the development of timelines, and budgets, relevant to the management of clinical development
Ensure timely publication of clinical trial results
Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies
Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists, and KOLs, as well as internal groups, including, research, CMC, operations, legal and business development
Assist with the coordinate the successful completion of documents with other groups
As needed/appropriate collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
Accountable for writing and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
5+ years of clinical research and/or clinical development experience within the biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of mentioned.)

Clinical Development Resume Examples & Samples

Basic mathematics and analysis
Effective written and oral communication skills
2+ years’ experience writing reports
Ability to collaborate in a team environment
Ability to formulate reports and present findings
Proficiency in using Microsoft Office programs, including but not limited to Word, Excel, PowerPoint and Outlook
Flexibility to work occasional nights and weekends
Ability to meet all hospital credentialing requirements, which may include background check, drug screen and vaccinations
Ability to travel up to 25% of the time
Experience in an OR environment
Experience giving presentations
Data-mining and analysis
Statistics

Clinical Development Functional Head Resume Examples & Samples

6) Gathers and shares best practices across teams or TAs. After major milestones have been reached the CDFH supports study and program team in performing “Lessons learned” workshops in support of a continuous improvement mindset
7) Supports the TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine/TCO, Global Medical Affairs), and internal decision boards
8) May work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences) to ensure alignment between Development and NIBR for pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligence, as needed
9) Supports career development of clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support. Helps to ensure consistency across CD in hiring and promotions of associates
10) Coordinates and contributes to medical/scientific training of relevant Novartis stakeholders on the disease areas and compounds/molecules and may serve as speaker TA/DU medical/scientific trainings
11) Leads or supports global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) in an effort to develop functional expertise in the DU and across Novartis Global Drug Development. Champions global initiatives at the TA/DU level
Advanced degree in life sciences/healthcare (or clinically relevant degree)is required. MD, PharmD, or PhD strongly preferred
Excellent negotiation and conflict resolution skills

Clinical Development Policy & Process Manager Resume Examples & Samples

Broad business experience resulting in knowledge of business process, written standards governance, organizational structure, accountabilities and roles
Understanding of the regulations that govern drug development
Project Management, Change Management, Risk Management and Facilitation; Application of recognized methodologies in line with current R&D practice
Broad understanding of the pharmaceutical industry
Ability to manage by influence rather than direct line control. Demonstrated success at influencing without direct authority
Working knowledge of application development, process improvement and business process re-engineering methodologies; trained ADP practitioner and facilitator, lean sigma skills
Credibility with customer; ability to rapidly build and effectively maintain key networks & relationships with customers
Ability to influence strategy, to anticipate and analyze complex and ill-defined business problems/opportunities and a track record of developing and delivering high quality solutions that will have broad impact organizationally
Able to build a project plan & business case (including costings and timelines) and lead a cross-functional team to deliver technical/business solutions
Proven ability to clearly convey information orally and in writing (technical documentation, presentations to business stakeholders, etc.) to audiences with varied and sometimes limited technical knowledge
Excellent interpersonal and communication skills, including the ability to establish and maintain good working relationships with peers, colleagues and management
Ability to work independently and make decisions with minimal supervision
Collaborating with colleagues in Clinical Development Policy and Process team to ensure effective delivery of new or revised processes and associated documents to the organization, share best practices and identify any changes to improve efficiencies within the business
Accountable for creating an implementation plan to ensure key clinical development processes assigned to the job holder are mapped end-to-end
Accountable for working with Process Owners to define strategy & approach for development & embedding of new processes to drive organizational change through influence, process facilitation and effective project management across multiple functions
Provide change leadership and engage staff to analyse their business process problems and identify or recommend solutions in alignment with business objectives and overall strategy
Facilitate cross-functional perspective on process needs, development, risk, dependencies

VP, Clinical Development, Neurology Resume Examples & Samples

Working with commercial colleagues to develop the therapeutic area strategy of identifying opportunities for development that address unmet needs
Interface with KOLs in the relevant therapeutic areas and Regulatory bodies to ensure optimal development of portfolio
Support Clinical Reserach teams in the Global Clinical Development of Phase II/III trial activities and oversight of Clinical Leaders in protocol development, study execution and interpretation of results
Work in close collaboration with commercial and medical affairs function to ensure alignment of development activities; ensure alignment with Global Specialty Medicines (GSM) in supporting our longer term therapeutic goals
Support the commercial organization with communication of development plans and results to pysicians, payors, sales and marketing teams, MSLs, etc. as needed
Manage a group of approximately ten physicians and scientists and provide leadership and guidance to them and their teams
Interface effectively with other Clinical Development functions and other departments, including Clinical Operations, Biometrics in design and conduct of the clinical programs
Participate in various governance bodies to support the development of TEVAs portfolio including Clinical Development Committee and Therapeutic Area Strategy Team
Highly important member of the R&D team makes go/no go decisions on the pipeline and key decision maker in what the company does in Neurology in the present and future
Create and maintain a positive and productive work environment and exhibit exceptional leadership capabilities by creating trust and respect within Neurology clinical development as well as other colleagues in Teva as well as externally
MD/DO and board certification in Neurology strongly preferred
Minimum of 10 years experience in clinical development function within a biotech or pharmaceutical company
Outstanding proven track record in Neurology drug development
Experience filing multiple New Drug Applications (NDAs) preferred
Strong relationships with Neurology Key Opinion Leaders (KOLs) across the country and globe
Well-developed leadership skills with the ability to influence, able to make decisions and stand by them. This individual will be highly visible at all levels of the organization and must be able to build trust and credibility walking in the door
Exceptionally sharp thinker; ability to push innovation and creative thinking. Strategic
Thinking, accountable and forward-looking; able to see a larger business picture
Flexible, able to wear many hats, work in a fast-paced environment and be open to change or the unknown
Collaborative and proactive, with a hands-on, roll-up-the-sleeves style and attitude
Excellent interpersonal, organizational, presentation and communication skills
Ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena
Hard working, energetic and passionate about making a difference
Highest integrity, committed to ethics and scientific standards
Travel 30% approximately

Trainee Clinical Development Sciences Resume Examples & Samples

Supports the clinical trial scientist(s) on conduct of the clinical study(ies)
Contributes to and reviews clinical science trial related documents as well as documents generated by other departments (Statistic, Operation, Data Management etc.)
Participates to trial related communication
Responds study protocol related questions
Performs data review and participates to the data interpretation
Performs literature review
The candidate would best have at least a Master of Science degree with possibly some experience in clinical research (other traineeship)
Good English skills (Spoken and written)
Able to integrate in a multi-functional team

Executive Director / VP, Clinical Development Resume Examples & Samples

Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)
The optimal candidate will demonstrate leadership qualities with significant knowledge and experience in developing Phase 1 & 2 protocols, analyzing pharmacokinetics, safety and efficacy data and advancing pharmaceutical large molecules (biologics) through preclinical, clinical stages, BLA/NDA submissions, and Advisory/Scientific Committee Meetings. The candidate will have authored relevant sections of regulatory submissions for INDs, CTAs and global filings and, ideally, will have an established a track record of publishing articles and abstracts in professional journals
Apply subject matter expertise towards formulation of clinical development plans, including selection of the proof of concept indication
In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine), is responsible for the design and authorship of study protocols and interpretation of clinical study data
Conduct medical monitoring and data listing reviews as necessary
Work closely with Clinical Operations colleagues on study implementation and oversight, which includes site and CRO selection and investigator meeting preparation
Accountable for safety across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues
In conjunction with Development colleagues, prepare strategy presentations, present and discuss data at relevant team, governance, external consultant, KOL, and regulatory meetings
Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR)
Participate in preparation for and conduct of meetings with Healthcare Authorities
Participate in the development and delivery of protocol training for investigator site and FPRX staff
Educate team members and vendors on the molecule and disease area and participating in internal continuing education activities
Contribute to the clinical development plan for one or more compounds, including review of the pre-clinical package after soliciting appropriate input, review and endorsement from key stakeholders for go/no-go development decision criteria
Assume the clinical leadership role for a project, representing the medical function on the project team and representing the team for medical discussions with the Development Committee
As a member of the project team, interface with Statistics, PK/PD, Regulatory, Clinical Operations, Diagnostics, Translational Medicine, Project Team Leadership and Management and other members of the extended project team(s)
In conjunction with the Clinical Operations, is responsible for the on-time and within-budget execution of protocols
May have functional responsibility for other clinicians or clinical scientists assigned to the project and may supervise and develop other colleagues, such as Drug Safety
Organize and prepare for Advisory Board meetings
Act as clinical representative for in-licensing activities such as due diligence reviews, reports, and development strategies
MD with a minimum of 10 years of demonstrated knowledge and experience in clinical research in an industry setting
Oncology training required with 3-5 years in practice
Prior management experience leading a team of Medical Directors and/or senior Scientists
Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Demonstrated scientific productivity (publications, abstracts, etc.)
Proven scientific writing skills and good communication skills

M HIS Clinical Development Analyst Resume Examples & Samples

High School diploma/GED or higher from an accredited institution
AHIMA or AAPC Coding Certification (e.g. RHIA, RHIT, CCS, CCS-P, CPC)
Minimum of five (5) years of hospital inpatient and/or outpatient coding experience
AHIMA Coding Certification (e.g. RHIA, RHIT, CCS, CCS-P, CPC)
Seven (7) or more years of hospital Inpatient and/or Outpatient Coding experience
3M HIS Codefinder experience
Proficiency with the CPT coding system
Proficiency with ICD-10 CM coding system
Proficiency with PCS coding system
Proven experience providing good communication and problem solving in a fast-paced environment
Knowledgeable of new trends in clinical management and health information systems for clinical and physician services areas
Proven ability to manage multiple tasks and meet deadlines
Excellent problem solving, analytical and organizational skills
Proven ability to work independently in a fast-paced environment
Proven ability to maintain a positive attitude in a team environment
Strong computer skills including proficiency in Microsoft Word, Excel and PowerPoint

Head of Clinical Development Resume Examples & Samples

Contribute to development of publication plan and directly oversee timely clinical data communication
MD degree required with Oncology board certification preferred. Minimum of 8 years of clinical development experience in oncology within biopharmaceutical, companies within a similar role (equivalent combination of education and experience may be considered)
Broad understanding of oncology, internal medicine and clinical pharmacology needed
Leadership skills to effectively manage a diverse workforce and strong communication skills to navigate within a cross-functional matrix environment and present scientific matters across and outside of the organization
Clinical experience should include the development of biomarkers for patient selection and drug efficacy Ideal candidate will have strong communication and collaboration skills Ideal candidate will have a network of external thought leaders within oncology, who serve as advisers
Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development, developed through success in gaining approvals. Experience in representing the sponsor in front of regulatory agencies preferred
Knowledge of in the day-to-day medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports)
Experience in obtaining global regulatory approvals and/or expertise in translational/early clinical development for innovative medicines preferred

Clinical Development Consultant Resume Examples & Samples

Primary point of contact for institutions to identify and proactively resolve business process barriers
Partnering with other functional partners and vendors interacting with the sites and serving as the single point of accountability for the site (site selection, site activation, enrollment, data delivery, issue management, and closeout)
Influence the development and implementation of site initiation/enrollment risk plans for clinical trials to ensure delivery on enrollment commitments
Own the issues management process at the site level, collaborating with Lilly partners, Quality, and other team members through both formal and informal interactions to resolve/escalate site specific issues when necessary
Oversee the delivery of data and clinical trial milestones at the site level
Leverage strategic knowledge of institution’s decision making process along with historical performance with other Lilly clinical trials to deliver mutually acceptable business solutions
Bachelor’s Degree in a scientific field or health-related field with no less than 2 years experience in Pharmaceutical Clinical Trials/Development/Sales and good working knowledge of Good Clinical Practice
Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed

Clinical Development Director Resume Examples & Samples

≥ 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 3-5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
Advanced knowledge of assigned therapeutic area
Demonstrated ability to establish strong scientific partnership with key stakeholders
Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process

Pediatrics Clinical Development Specialist Resume Examples & Samples

Ability to communicate verbally with individuals from diverse backgrounds, including patients and their family members, Associates, management and physicians
Ability to work without close supervision and to exercise independent judgement
Role Model and Change Agent: Serves as a role model/change agent to promote innovation and best practices in the clinical setting and professional and technical development of Associates
Consultation: Provides consultative services to internal and external customers

ED Clinical Development Specialist Resume Examples & Samples

Ability to understand and prepare moderately complex written materials, such as policy and procedure manuals and financial indicators
Ability to organize multiple tasks and projects and maintain control of own and other’s workflow
Orientation: Ensures an appropriate climate for learning and facilitates the adult learning process for new Associates
Core Educational Offerings: Ensures an appropriate climate for learning and facilitates the adult learning process for all Associates
Research Integration: Collaborates with all levels of hospital leaders and staff to integrate relevant research outcomes into learning activities and clinical care

Clinical Development Medical Director Resume Examples & Samples

4) May be the Program Manager of other associates (e.g.., CTH, CSE)
5) May act as study medical monitor
6) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
8) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
11) Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
12) May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
≥ 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry

Clinical Development & Analytics Associate Director Resume Examples & Samples

3) Drive cross Development Unit alignment of processes as part of the deliverables of CD&A and drive implementation at the Unit level
4) Lead QA/SOP activities within CD&A, serve as clinical representative on Process, Training & Governance Board (PTGB) which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicabilities; performing collegial reviews of SOPs and P&SPs
5) Can serve as a Lead SME or as an SME
6) Drive best practices by identifying clinical training needs and development opportunities. Identify cross-functional issues, gaps and lead global process improvement work streams as applicable
7) In collaboration with QA, responsible to implement quality initiatives as needed: inspection readiness, records tracking, support audits preparation and follow up
8) Drive efficiency and track performance against metrics
9) From a people standpoint, work with the CD&A to make sure that CD&A Leadership is informed at all points about key issues and has access to information when needed
Strong understanding of Pharmaceutical Development processes, objectives and strategy across various disciplines /functions (e.g., development, commercial, providers, payors)
≥5 years technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia
Strong scientific background in basic and clinical research with good understanding and knowledge on drug development
Strong skills in leading and managing cross-functional projects with significant (visible) business impact
Excellent influencing, negotiation and conflict resolution skills
Excellent analytical, process-oriented and data driven mind-set
Action orientated and competitive: make things happen - exhibit a strong will to win and drive change. Take responsibility for decisions and execution
Expertise in organisation dynamics
Needs to be able to work independently, resolve issues with minimal supervision and understand when to escalate
Act as change agent and actively generate and foster creativity and innovation in CD&A
Strong project management skills, able to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
Leadership presence with the ability to present and interact with senior management

Clinical Development Specialist Resume Examples & Samples

Coordinates the implementation of division-wide standardization, utilization, integration, and optimization activities
Develops annual business plans and provides quarterly updates, which include both strategic plan and tactical actions for assigned territory to ensure accomplishment of established targets
Works with TSR to design and develop base education/training materials to support staff training and continued education
Provides product training live and virtual to maximize product utilization, upgrade opportunities, growth and adoption
Interfaces closely with dentist to increase procedural knowledge and product satisfaction
Identifies additional sales opportunities for the customer and communicates appropriate information to assigned Territory Sales Representatives
Regularly analyze sales/market data, customer demographics and requirements to formulate strategic plans and provide feedback to sales management to encourage the development of successful marketing tools, promotions, and/or messages
Provides unique solutions to clinical customers to ensure effective and efficient product use
Participates in special projects as needed and performs other duties as assigned
Works effectively with internal colleagues and provides feedback on Inside Sales, Customer Service, Marketing, Sales Training and Administration, and Human Resources concerns
Demonstrated ability to establish and build strong relationships
Demonstrated strong customer focus and successful sales track record
Excellent teaching abilities
Must have current /active state-issued driver’s license
Demonstrated efficient use of resources and knowledge of dental industry
Strong hunter mentality
Demonstrated advanced computer skills including but not limited to MS Office Suite
3-5 years of experience in clinical development or medical device sales

Clinical Development Associate Resume Examples & Samples

Cover Letter
A NACES International Equivalency Evaluation for any foreign degrees
Internal candidates must provide their past three performance appraisals

Head of Clinical Development Resume Examples & Samples

Active New York State Registered Nurse, Nurse Practitioner, or Clinical Social Worker license
5-15 years of experience with chemical dependency/drug and alcohol rehab
Prior leadership experience

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