Director, Clinical Development Resume Samples
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Director, Clinical Development Resume Samples
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JE
J Effertz
Joey
Effertz
3017 Runolfsson Lakes
San Francisco
CA
+1 (555) 533 6008
3017 Runolfsson Lakes
San Francisco
CA
Phone
p
+1 (555) 533 6008
Experience
Experience
Philadelphia, PA
Director, Clinical Development
Philadelphia, PA
Schmeler LLC
Philadelphia, PA
Director, Clinical Development
- Assisting in accomplishing department and corporate objectives
- Acting as Medical Monitor for Ionis-sponsored clinical trials (if medically qualified)
- Interacting with regulatory agencies, in concert with the Regulatory Affairs Department
- Developing external advocates for the company’s technology, products and direction
- Performing clinical study data review and analyses in conjunction with Biometrics
- Making critical strategic decisions
- Developing, and keeping current, the clinical development plan/s
Philadelphia, PA
Medical Director, Clinical Development
Philadelphia, PA
Abbott, Maggio and McLaughlin
Philadelphia, PA
Medical Director, Clinical Development
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
- Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals
- Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
- Conduct literature reviews and prepare summaries to support clinical development programs
- Provide medical monitoring to multiple oncology clinical trials
- Development of clinical protocols and amendments, investigator brochures, and clinical study reports
present
Houston, TX
Senior Director, Clinical Development
Houston, TX
Rippin, Berge and Buckridge
present
Houston, TX
Senior Director, Clinical Development
present
- Represents CD in sub-teams and addresses CD study or other program-specific questions, provides updates and delivers presentations
- Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
- 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
- Helps coordinate the successful completion of documents with other groups
- Develops and provides input for clinical presentation slides and other materials for meetings and ongoing communications
- Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc
- Writes 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
Education
Education
Bachelor’s Degree in Finance
Bachelor’s Degree in Finance
Northern Illinois University
Bachelor’s Degree in Finance
Skills
Skills
- Excellent organizational and time management skills, ability to lead and manage multiple complex projects
- Strong negotiating skills, knowledge of legal contracts and experience with RFPs and competitive bidding processes
- Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
- Ability to develop strategic plans, recommended course of action and implement
- Strong written and oral communication skills
- Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships
- Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community
- Knowledge and experience in the CNS therapeutic area
- Ability to work proactively and effectively, with creative problem solving skills
- Thorough knowledge and understanding of FDA, GCP, and ICH regulations and guidance
15 Director, Clinical Development resume templates
Read our complete resume writing guides
1
Director, Clinical Development, Immunology Resume Examples & Samples
- Responsible for design, execution, and reporting of Phase 2 and 3 clinical trials
- Oversee the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
- MD or advanced degree (e.g. PhD or PharmD) required
- Board Certification in Gastroenterology, Rheumatology or Dermatology would be desirable
- Experience in clinical trial monitoring is an asset
- Ability to work in a matrix environment with cross functional teams is essential
2
Exec Director Clinical Development Resume Examples & Samples
- Provides oversight for all assigned BU 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
- Forecast, prioritize and direct staff to achieve on-time quality sponsor deliverables, contractual project requirements, utilization goals and profitable results
- Evaluates progress of BU projects and assigned staff to ensure the meeting of targets for utilization, realization, and timelines
3
Associate Director, Clinical Development Resume Examples & Samples
- Reviews clinical sections of ANDA or NDA for quality control and regulatory compliance
- Manages and drives clinical study timelines with cross-functional teams, CRO's and business partners to ensure deliverables are met on schedule. Monitors progress and follows up with team members and line managers when issues develop
- Contributes to CRO selection activities
- Responsible for the Clinical Information Management System for study scheduling, status reporting and any required safety reporting
- Updates Clinical Trials.gov database with applicable trials as required
- Manages Bio study and sample storage payments
- Oversees study documentation archival process
- Prepare and liaise with investigator sites for FDA Inspections
- Review and assure quality of clinical study reports
- Respond to FDA requests for clarification
- PhD/PharmD/MD/MBBS: 3 to 5 years with experience in clinical development and clinical trial management preferred
- MS/MPharm: 5 to 7 years of clinical development experience preferred
- 7 to 10 years with BS with industrial/CRO clinical experience preferred
- 3 years or more FDA clinical review experience preferred
- Extensive experience in conducting clinical bioequivalence trials
- Experience with preclinical (GLP) DMPK is a plus
- Working experience in a global team, team player
- Comfortable with multitasking environment
4
Associate Director, Clinical Development Resume Examples & Samples
- MS/MPharm: 5 to 7 years of clinical development experience
- 7 to 10 years with BS with industrial/CRO clinical experience
- 3 years or more FDA clinical review experience
5
Senior Director, Clinical Development Resume Examples & Samples
- Represents CD in sub-teams and addresses CD study or other program-specific questions, provides updates and delivers presentations
- Develops and provides input for clinical presentation slides and other materials for meetings and ongoing communications
- Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc
- Writes 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
- Coordinates submissions to scientific meetings and/or other appropriate venues or groups
- 12+ 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.)
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
- Emerging research experience in rare diseases
6
Assoc Medical Director, Clinical Development Resume Examples & Samples
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP)
- Establish appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP
- Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics
- Three (3) to five (5) years of experience in clinical and/or translational research with a proven record of achievement on independent research projects
- Clinical research experience in epilepsy is preferred
- Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment
- The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills
7
Director, Clinical Development Resume Examples & Samples
- Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical studies, before during and after conduct of studies, and identify/resolve issues related to study design that arise during study
- Provide medical monitoring and direct interaction with investigational sites, investigators, and when appropriate Key Opinion Leaders
- Provide medical expertise where needed (which may include assisting colleagues in Pharmacovigilance)
- Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements
- Provide program level medical oversight of information included in regulatory documents including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD submissions, and responses to questions from regulatory authority or EC/IRBs
- Support preparation of abstracts, manuscripts, presentations, and materials for Advisory Meetings
- Present protocols and supporting presentations at Investigator Meetings and as needed for other meetings or training purposes
- Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews
- Provide medical/scientific review of statistical analysis
- Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, coding, report development and database lock processes
- Keep up to date on scientific and medical progress in the area of development and actively develops and maintain relationships with outside experts. May serve as a liaison by representing the company in outside groups
- Contribute to process creation and SOP writing and updating as needed
- Participate in due diligence work as needed
- Requires an MD or DO degree, preferably board eligible. Specialization in pulmonary or infectious diseases is a plus. Experience in rare pulmonary diseases is desirable
- At least 3 years of clinical development experience in the pharmaceutical/biotech Industry. Alternatively, a minimum 5 years of experience conducting clinical trials outside the Pharmaceutical Industry will be considered
- Basic knowledge of therapeutic area
- Working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies
- Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders, within and outside of Insmed
- Must have excellent communication skills (verbal and written)
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness
- Must have strong analytical skills
- Must work well both independently and in teams, have excellent time management skills and be able to work well under pressure
- Vendor management experience is a plus
- Up to 35% travel, both domestic and international, with periods of 50% and more travel
- Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
- Must have a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies
- Must be a team player with respect for contributions of other team members
8
Medical Director, Clinical Development Resume Examples & Samples
- Provide medical monitoring to multiple oncology clinical trials
- Lead project teams to design and implement clinical studies
- Write protocols, investigator brochures, clinical study reports and review clinical trial documents
- Conduct investigator meetings and lead site initiation visits with clinical trial investigators
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate findings from research and nonclinical studies into clinical development opportunities
- Interact with clinical investigators and thought leaders
- Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
- Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
9
Director, Clinical Development Resume Examples & Samples
- Devise strategy for, develop and implement clinical studies for investigational medicines and new indications for approved medicines
- Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
- Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjuction with project team members, regulatory affairs and senior management
- Serve as medical representative with regulatory agencies
- Three plus years of pharmaceutical development experience in hematology/oncology
- Demonstrated scientific and therapeutic expertise
- Experience of interactions with regulatory agencies
- Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
- Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships
- Medical degree, MD or equivalent, with experience in hematology/oncology
10
Medical Director, Clinical Development Resume Examples & Samples
- Development of clinical protocols and amendments, investigator brochures, and clinical study reports
- Conduct literature reviews and prepare summaries to support clinical development programs
- Demonstrates a passion for helping patients with cancer and for the science of oncology
- Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals
- Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies
11
Medical Director, Clinical Development Resume Examples & Samples
- Works on several trials or programs involving Phase I and Phase II proof-of-concept studies for neurological/CNS indications
- Develops clinical development plans, clinical protocols, investigator’s brochures and other key program documents in collaboration with cross functional development teams, with emphasis on scientific and safety matters
- Represents Vertex to outside medical/scientific experts in the development of the clinical protocols, solicitation of input and opinion, and presents at conferences and symposiums in the therapeutic area. Serves as a leading member, or participant, at internal review groups
- Serves as Medical Monitor for clinical trials, ensuring compliance with GCP regulations and monitoring the safety of enrolled subjects
- Uses innovative thinking to independently solve clinical development problems
- Contributes to the production of regulatory documents such as IND and CTA filings, annual reports and EU regulatory submissions
- Provides medical leadership for statistical analysis plans, data interpretation and compilation of final study reports
- MD, MD/PhD, DO or equivalent ex-US medical degree(s) and 2-3+ years of clinical research experience (academic or industry)
- Board certification in Neurology, Psychiatry or a related medical specialty. Clinical experience in pain, neurodegenerative disease or epilepsy is highly desirable
- Excellent oral and written communication skills and experience with publications
- Ability to work collaboratively in a dynamic team-based (matrix) environment
- Possess a basic understanding of applicable US and EU regulations, the drug development process, biostatistics and pharmacokinetics
- Experience in filing and defending US IND's or similar ex-US regulatory submissions
12
Director, Clinical Development & Operations Resume Examples & Samples
- Facilitates and seeks to accelerate the development and implementation of clinical trials to meet or exceed the clinical development plan (CDP) within budget. Holds overall responsibility for the conduct and reporting of clinical trials
- Manages studies of one or more products independently and resolves simple to complex issues to move clinical development of products forward
- Manages direct reports to accomplish clinical, product life cycle, and corporate goals
- Responsible for the direction and management of clinical vendors and contractors and the monitoring of clinical trials to International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines. Oversees the preparation and management of trial master files (TMFs) and clinical Standard Operating Procedures (SOPs)
- Oversees management of clinical supplies and clinical supply vendors
- Oversees the selection of clinical trial sites and investigators. Oversees and tracks timely resolution of deficiencies identified in monitoring reports, audit report(s), project calls and updates or other sources. Simultaneously manages several multi-center trials, including registration trials
- Trains internal and third party team members as appropriate to meet business needs. Participates in the negotiation of timelines and resource needs with both internal and external decision makers. Coordinates and manages activities including auditing and/or co-monitoring of Contract Research Organization’s (CROs) or independent contractors
- Works with Legal to prepare contracts and execute work orders
- Responsible for operating within approved clinical trial budgets
- Facilitates communication with CRO’s/ independent contractors and third party vendors. Initiates contracts, approves payments and ensures communication to team of changes to the budget and operating plan
- Writes, reviews, or edits protocols and interim study reports. Updates Investigator Brochures, and directs writing and review of Clinical Study Reports
- Supports the preparation of global regulatory submissions including Investigational New Drug (IND), IND Annual Reports, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) and any regulatory updates
- Manages Safety reporting for clinical trials and any safety updates as required by SOP, applicable regulation, and/ or ICH/GCP
- Contributes to quality improvement through writing/editing SOPs, developing and implementing tools, identifying and remedying gaps in process or execution
- BS degree in related field, scientific background. Advanced degree preferred
- 7+ years experience in pharmaceutical clinical research including at least 3 years managing clinical studies
- Strong comprehensive and analytical skills
- Proficient in Microsoft Office and Adobe Acrobat
- Strong knowledge of Good Clinical Practices including US 21 CFR and ICH E6. Able to establish exUS applicable standards as needed
13
Director, Clinical Development, Immunology Resume Examples & Samples
- Oversees the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
- Board Certification or advanced training in Rheumatology would be strongly preferred
- Experience in scientific investigation into mechanisms of disease in Rheumatology would be an asset
- Approximately 10%to 20% annual travel may be required (domestic and international)Clinical Research non-MD
14
Associate Director, Clinical Development Resume Examples & Samples
- Provide clinical/scientific input during the development, execution and completion of clinical trials
- Monitor clinical trials for safety
- Work in conjunction with Product Safety to insure timely reporting of safety signals to regulatory authorities
- Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs and senior management
- Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
- Experience in leading the design, conduct, analysis and reporting of clinical studies, including interactions with regulatory agencies
- Excellent organizational and time management skills, ability to lead and manage multiple complex projects
- Three plus years experience in medical specialty, hematology/oncology preferred
- Ability to work proactively and effectively, with creative problem solving skills
- Travel up 10%-20% of the time
15
Director Clinical Development Isatuximab Resume Examples & Samples
- Contribute to the strategy and manage the overall conduct of clinical development plans, including review of the pre-clinical and clinical package in collaboration with the project MD
- Act as a medical team leader to ensure operational execution of all program clinical studies according to the protocol and study plan (under direction of the physician for medical decisions)
- Act as a scientific program manager and work transversally with all clinical study directors to harmonize essential sections of the protocols, reports and operational plans across the program
- Prepare and review the protocol including study design and amendments and in addition, the IB, clinical sections of IND/IMPD, CTAs filings, annual reports, clinical study reports, risk-management plans, and regulatory documents (INDs, NDAs) under the supervision of the project physician or project head
- Collaborate closely with clinical operations for protocol input and to ensure study design feasibility
- Contribute to the preparation of essential clinical study documents (CRF, DMP, DVP, IND, CTAs, SAPs, charters)
- Identify core competencies of specific expertise for potential study sites for all phases of oncology trials from a scientific/strategic perspective
- Assist in the conduct of study site initiation visits (preparation, personnel training, etc.) and study start-up + close-out meetings, global investigator meetings (preparation of the scientific and medical communication)
- Lead Advisory Boards (content and strategy)
- Prepare and/or organize and/or participate in Steering Committee, Data Monitoring Committee and any other ad-hoc committee meetings
- Provide scientific support for clinical data review and interpretation including safety and efficacy
- Contribute to overall study conduct and data validation with clinical operations (DM, CTM, Stat, Reg. Affairs) and review Clinical Study reports
- Perform data review, interpretation and analysis to assess the impact on project objectives and deliverables
- Perform medical review of data under the direction of the study physician / project head including review of the safety and efficacy data (“DDR”, PV, coding) when appropriate and support the medical review of data prepared by the clinical trial team
- Participate in the preparation of registration clinical documentation (labeling, CTDs, overview summaries)
- Participate in meetings with health authorities for development and registration purposes
- Prepare responses for registration clinical questions
- Routinely interface with discovery, safety sciences, statistics, PK, pharmacovigilance (e.g. SAEs and narratives), regulatory, health economic (studies, planning, questionnaires administration), development operations and clinical operations and other members of the extended project team to deliver studies according to the clinical development plan
- Author and review clinical abstracts and presentations for conferences when appropriate
- Provide feedback to the clinical study team regarding study conduct (contribute to discussions regarding adjustments in the study and/or strategy based on the data)
- Work with all global project team members including commercial team for development input into strategic decision making and market access plans
- Based on expertise may be asked to work with OBO and business development to provide clinical and scientific input as a member of scouting and due diligence teams
- At least 8 years of product development experience, of which at least 5 years include direct clinical research experience including drug development and clinical program management
- Strong analytical skills including the assessment of scientific data and medical literature
- Experience writing abstracts/manuscripts/study reports is strongly desired
- Ability to communicate effectively on complex medical/scientific issues and build consensus
- Working knowledge of GCP and SOPs Ability to synthesize and explain complex topics to non-experts
- Ability to collaborate effectively with all personnel involved in clinical research and the global project team
- Experience in submission activities, discussion and negotiation with health authorities
- Expertise across hematologic malignancies and understanding of translational medicine
- Leadership, capacity to coordinate several activities and stakeholders
- Translation of strategy into operational objectives and goals. Delivering results with speed , quality and value
- Quality decision making – balance of timing and data to support rational
- Communication, networking, and influencing skills to build mutual beneficial solutions and partnership
- Ability to appropriately challenge status quo and propose solutions
16
Director, Clinical Development Resume Examples & Samples
- Works closely with BD&L team and provide support for due diligence of new opportunities, and work with external partners on co-development projects to ensure timely execution of projects leading to ANDA submission
- Reviews clinical study documentation submitted by Sandoz Business Partners for GCP as well as US regulatory compliance as part of due diligence and co-development processes
- Evaluates clinical programs for overall project success, cost and timelines for Business Development and Portfolio groups
- Responsible for the execution of assigned clinical trials in the US (e.g. trial timelines, meetings, milestones, resources, eligibility, enrollment and data consistency) in alignment with Global Clinical Development
- Research and develop protocol designs and clinical FDA submission strategies; liaise with key opinion leaders, statisticians and consultants, as needed, to accomplish
- Act as primary liaison with all internal and external partners regarding clinical projects
- Manages Purchase Order requisition and invoice payment maintenance
- Coordinates Bio-study Sample shipments to CRO’s with document preparation and regulatory requirements for sample shipment
- Oversees process for execution of master service agreements, CDA’s, consulting agreements, contracts and other study documents
- Prepares Trial Master Files and is responsible for the financial, legal and product information documentation according to good clinical practices (GCP)
- Manages Bio-study and sample storage payments
- Provide regulatory clinical strategy and input as a subject matter expert in bioequivalence and pharmacokinetics to internal drug development programs
- PhD/PharmD/MD/MBBS: 10 years or more with experience in clinical development and clinical trial management of bioequivalence and pharmacokinetic studies in healthy subjects or patients. Experience at a director level or above in Bioequivalence and pharmacokinetics in generic industry or a CRO is preferred
- MS/MPharm: 15 years or more of clinical development experience in Bioequivalence and pharmacokinetics
- 10 years or more FDA clinical review experience in bioequivalence and pharmacokinetics
- Thorough knowledge of clinical requirements for generic drugs
- Ability to work in an outsourcing environment with external partners
- Ability to work in a matrix environment
17
Director, Clinical Development, Neuroscience Resume Examples & Samples
- Primary responsibility for trial setup, coordination, and oversight of trial execution of assigned studies
- Medical monitoring and evaluation of safety, tolerability and adverse events in clinical trials
- Provides clinical support for Regulatory Affairs activities for a clinical program (e.g., health authority documents/responses, labeling, filing activities)
- Interpretation and reporting of clinical research results for regulatory submission and publication
- Review/contribute and author presentations, medical publications, posters, etc. emerging from the team and its affiliates
- Requires a minimum of a medical degree (i.e. M.D. D.O., M.B. or equivalent), and completion of post-doctoral training in Psychiatry
- Must have at least 3 years of clinical psychiatry research experience, preferably in the area of mood disorders
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and contributions to regulatory filings is required
- May require approximately 20% travel (domestic and international)Clinical Research MD
18
Director, Clinical Development Resume Examples & Samples
- Skills in team building
- Skills in information technology
- Master's Degree Preferred
- 5-7 years of Management experience
- Pharma/CRO Management
19
Director Clinical Development Resume Examples & Samples
- General knowledge of financial budgeting models
- Skills in communication (oral, written and presentation)
- Skills in organization and problem solving
- 5-7 years of Oncology Research experience
20
Director, Clinical Development Resume Examples & Samples
- Negotiate and maintain national and regional contracts for direct and indirect spend categories
- Develop short and long term strategies for each contract and product category
- Manage down the costs of assigned spend categories by executing various sourcing strategies
- Proactively identify and achieve savings opportunities and operational improvements
- Proactively analyze spend data and seek out cost containment and cost savings opportunities
- Monitor compliance with DaVita’s product formularies and ensure contact terms are met
- Conduct RFP processes and work with legal team to put new contracts in place
- Work with cross functional teams to evaluate new products for use in our dialysis centers
- Drive operational changes in support of process improvements & clinical initiatives
- Lead and/or support product and policy changes across the company
- Minimum: Over 7 years and up to including 10 years of management experience
- Ability to develop strategic plans, recommended course of action and implement
- Strong analytical skills - advanced excel and think analytically
- Excellent verbal and written communication skills. The position requires a have high level of interaction with teammates in various departments and at all levels throughout DaVita, including senior management, and extensive interactions with key vendor partners
- Strong negotiating skills, knowledge of legal contracts and experience with RFPs and competitive bidding processes
- Excellent computer skills in Excel, PowerPoint & Word
- Personal values in line with DaVita’s values of Service Excellence, Integrity, Team, Continuous Improvement
21
Senior Director, Clinical Development Resume Examples & Samples
- Awareness of advances in medicine and in the industry
- Excellent communication, oral, written and presentation skills
- 10 + Years of management experience
- 10 + years of oncology research experience
- Pharma/CRO management experience
22
Executive Director, Clinical Development Resume Examples & Samples
- Participate ina and lead cross-functional strategy and leadership teams
- Interpret clinical trial data and prepare reports, regulatory submissions and publications based on the results
- Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas
- Serve as lead medical representative with regulatory agencies
- Lead clinical advisory board meetings to obtain strategic input into clinical program development
- Serve as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
- Provide clinical input on licensing opportunities
- Eight plus years of pharmaceutical development experience in hematology/oncology
- Demonstrated outstanding leadership on multiple development projects and teams
- Demonstrated scientific and therapeutic experience
- Extensive experience in leading the design, conduct, analysis and reporting of clinical studies, including experience in preparation of NDAs/BLAs to US and International regulatory agencies
- A scientific track record demonstrated by publication record in peer reviewed journals
- Demonstration of Jazz values in previous employment
- Ability to work proactively and effectively using creative problem solving skills
- Track record of relevant scientific publications
- Travel required (up to 10%-30% of the time)
- Medical degree, MD or equivalent (DO, PharmD, PhD), with extensive experience in hematology/oncology. Board certification or advanced training in hematology and/or leukemia preferred
23
Executive Director, Clinical Development Resume Examples & Samples
- Write and/or facilitate the writing of clinical project management documents such as project scope definition documents, project training materials, monitoring plans and monitoring tools, study protocols, safety plans, recruitment plans and closeout plans, etc
- Coordinate/execute operational aspects of assigned clinical studies (including identification, selection, qualification and management of clinical investigators and third party vendors, test article release to sites, site monitoring activities, ongoing review of key study data, etc.)
- Review and approve monitoring reports and follow-up letters prepared by the project CRAs for assigned studies
- Plan and review the analysis of clinical data and determine the ultimate interpretation of results
- Ensure the assigned trials are “audit ready” at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial). Ensure that any audit observations are addressed appropriately and in a timely manner
- Develop and maintain project schedules, with key metrics, for clinical projects to ensure optimal study management. Identify and resolve issues that impact project scope, resources. or timelines and communicate to senior management
- Develop and monitor overall clinical development budget for assigned projects ; effectively manage resources, funding and expenses
- Serve as principal medical monitor overseeing all aspects of the safety monitoring in the clinical development programs
- Prepare clinical sections of regulatory documents such as investigator brochures, INDs, NDAs, BLAs, background packages for FDA meetings, etc. Provide medical review and approval of regulatory documents pertaining to the work of the clinical team
- Cultivate and nurture strong collaborations with key opinion leaders, Investigators, research centers and corporate partners
- Collaborate with Business Development, Senior R&D and Commercial leadership to identify, recommend and develop strategic alliances, partnership and licensing opportunities requiring due diligence work and strategic input
- MD and US medical license, with 14+ years of clinical drug development related experience in the research and development of novel biologics, particularly within the field of inflammation
- Expertise in preclinical, translational, and early clinical development within the field of inflammation
- Track record of program leadership and achievement of goals and deliverables, of effective collaboration, effectiveness in team settings, and team leadership
- Firm understanding of the mechanistic basis of human inflammatory disorders
- Thorough understanding of clinical protocols and regulatory processes
- Excellent understanding of the drug development process
- Thorough knowledge of FDA requirements, Good Clinical Practices, and pharmaceutical clinical development
- Demonstrated success establishing, communicating and driving a vision and strategy for a therapeutic area/product, and develop an integrated plan of action including milestones and endpoints and ensure executional excellence
- Effective communication and interpersonal skills, with the ability to successfully articulate strategies, experimental results and analysis to various constituents such as governance committees, project teams, clinical sub-teams, and senior management to build enthusiasm, passion and commitment, and to gain approval /sponsorship for projects
- Ability to work effectively in as a team player in a complex, changing environment, with the ability to build morale and group commitments to goals and objectives
- Ability to garner support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change
- Ability to define issues, collect and analyze complex data, and draw valid conclusions
- Position will require domestic and international travel
24
Medical Director, Clinical Development Resume Examples & Samples
- Board certified Neurologist
- Recent clinical experience in Neuroscience
- Experience of leading Neuroscience development programs
- Experience in early stage drug discovery and early phase drug development
- Breadth of clinical knowledge including a solid external clinical network within Neuroscience
- A higher qualification (e.g. PhD) within a Neuroscience discipline
- Drive TA-wide experimental medicine initiative through close coordination with clinicians involved in the indication programs
- Serve as the point neurologist to advise on
- Biomarker development and strategy
- Patient selection strategy
- Clinical study design
- Work closely with discovery program leader and clinical trial physician of different programs within the indication
- Contribute to and serve as key liaison for the indication to develop, strengthen, and align pre-competitive initiatives
- Engage, establish and drive value-adding partnerships with academic medical centers to enable success of FTIH and PoC studies of key indication assets
- Work with Safety Scientists and Safety Physicians to ensure complete and accurate reporting of safety information to regulatory authorities including DSUR
- Act as a medical monitor and oversee other medical monitors of clinical studies and be the point person for Medical Governance
- Development of Safety Update Reports, Investigational Brochure updates, Clinical Study Reports, protocol/protocol amendments
- Support team interactions with FDA and EMA (briefing document creation / Face to face meetings / teleconferences)
- When requested, work closely with other neuroscience programs
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Director, Clinical Development Resume Examples & Samples
- Scientific Credibility: Demonstrated by the ability to understand the scientific principles of the study design, the compound class, relevant therapeutic area and how an individual study contributes to the development of a drug. In particular they will have experience of techniques and practices that are used to deliver the study outputs
- Judgment: Evidence of sound scientific and ethical judgment. The outputs from each study must be supportable under the scrutiny of regulators or the wider scientific community. Each study must be conducted in the correct ethical and scientific manner, adequately documented and any deviations or discrepancies dealt with contemporaneously. The job holder understands the key customers for each study and knows when to appropriately request medical oversight of clinical issues
- Leadership: Demonstrated ability to lead the resolution of issues related to individual or groups of studies. Capable of leading a matrix team in the delivery of study objectives including guidance of less experienced staff in the delivery of their roles. Capable of coordinating the delivery of multiple studies, at times simultaneously, within a development plan
- Teamwork: Established reputation for working within a team and developing cohesiveness for all team members. The individual is able to overcome technical, business and cultural differences to meet objectives. Actively promotes and utilizes the skills and contributions of others within the project and line
- Corporate Agility: Adaptable to the dynamic environment within their role, demonstrating an ability to alter direction at short notice to deliver business advantage to the organization
- Decision Making: Makes decisions which balance risk/benefit with clear understanding of impact on project and takes action to mitigate risk where appropriate
- Communication: Applies effective verbal, written and presentation skills. Good organizational skills
- Advanced Degree
- Experience in dermatology development
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Director, Clinical Development Resume Examples & Samples
- Developing, and keeping current, the clinical development plan/s
- Design of clinical trials and writing/review of protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports etc.)
- Making critical strategic decisions
- Leading action-oriented, project team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes
- Identifying emerging risks and managing them with the Project Manager
- Acting as Medical Monitor for Ionis-sponsored clinical trials (if medically qualified)
- Interacting with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan
- Maintaining medical/scientific standards, educating team members and managing the Scientific Advisory Board (SAB)
- Involvement in management (and other oversight) committee meetings, including Development Management Committee (DMC) and Research Management Committee (RMC)
- Interacting with regulatory agencies, in concert with the Regulatory Affairs Department
- Representing project(s) to corporate partners, investors and clinical investigators as required
- Developing external advocates for the company’s technology, products and direction
- Facilitate the effective conduct of clinical trials by
- Developing and maintaining excellent working relationships with investigators
- Ensuring that all GCP requirements are consistently met
- Delivering high quality scientific presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff
- Providing guidance and/or training for external personnel/parties involved in Ionis' clinical studies
- Performing clinical study data review and analyses in conjunction with Biometrics
- Facilitating, assisting and/or participating in the preparation of clinical study manuscripts by Investigators, internal personnel and/or contract writers
- Maintaining clinical and technical expertise in the therapeutic area by reviewing scientific journals, attending scientific and key technical meetings and partnering with company medical, research and commercial teams
- Assisting in accomplishing department and corporate objectives
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Associate Director, Clinical Development Resume Examples & Samples
- Work in conjunction with Product Safety to insure timely reporting of satefy signals to regulatory authorities
- Identify and interact with key opinion leaders and academic organizations toassure incorporation of latest clinical thinking and guidelines into clinical development plans
- Three plus years experience in medical speacialty, hematology/oncology preferred
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Director, Clinical Development Resume Examples & Samples
- Contributes to the preparation of clinical protocols, Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific/regulatory/medical standards
- Contributes to data analysis planning and interpretation of clinical trial results
- Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required, and working with the safety group to ensure adequacy of safety monitoring and reporting
- Contributes to developing clinical components of NDA and sNDAs
- Contributes to company responses to health authorities and ethics committees for ongoing clinical programs to ensure timely registration and initiation of trials globally
- Contributes to clinical responses to FDA (or other health authority) queries. Contributes to presentations to key internal and external meetings (FDA, etc.)
- Contributes to the development of presentation materials for Scientific Advisory Board meetings, national and international scientific meetings, and investigator meetings
- A doctoral degree (PhD or MD) in scientific or life sciences field
- A minimum of 5 years' experience in pharmaceutical industry, ideally with a minimum of 5 years managing clinical study conduction
- Thorough knowledge and understanding of FDA, GCP, and ICH regulations and guidance
- Knowledge and experience in the CNS therapeutic area
- Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community
- Ability to work both independently and effectively in a cross-functional team environment
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Director Clinical Development, Immunology Resume Examples & Samples
- Responsible for monitoring safety of clinical trials and providing scientific leadership in the area of responsibility
- Provide scientific & clinical leadership of Phase 2 and 3 clinical trial teams
- Leads the development of the Integrated Study Plans (concept sheets, project plans, protocols, CRFs, operational and analytic plans) and study summaries, IND submissions, and technical reports. Provides input to strategic decisions regarding therapeutic indications
- Authorship of abstracts and manuscripts for publication based on clinical trial data
- Presents data and scientific information to the organization at all levels
- Builds credible relationships with opinion leaders and External alliances for partnered products when relevant
- MD is required
- Experience in pharmaceutical drug development (academic or industry setting) is highly desirable
- Strong leadership skills and the ability to influence is necessary
- Approximately 10% to 20% annual travel may be required (domestic and international)Clinical Research MD
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Director Clinical Development, Immunology Resume Examples & Samples
- Provides scientific & clinical leadership of Phase 2 and 3 clinical trial teams
- May participate in evaluation of in-licensing opportunities and contribute to early development programs
- Approximately 10%to 20% annual travel may be required (domestic and international)Clinical Research MD
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Executive Director, Clinical Development Resume Examples & Samples
- Minimum 9 years of experience in the biotechnology / pharmaceutical industry with at least five years of hands-on clinical trials management and/or clinical development teams. Experience in CNS drug development highly preferred
- Ability to multi-task and manage several projects in parallel, paying attention to detail
- Ability to forge cross-functional working relationships with internal teams and external project partners
- Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion
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Senior Director, Clinical Development Resume Examples & Samples
- MD required
- 5-7 years of experience in the biotechnology / pharmaceutical industry with at least five years of hands-on clinical trials management and/or clinical development teams. Experience in CNS drug development highly preferred
- Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems
- Experience with all aspects of management of clinical trials from inception to completion across all phases of development including study design
- Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management
- Thorough knowledge of clinical medicine and clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)
- Expert knowledge of Good Clinical Practice (CGP)
- Ability to travel up to 30% of time
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Director Clinical Development Resume Examples & Samples
- Representing Clinical Development as a key team member on the Clinical Trial Team
- Performing clinical data reviews
- Ensuring resolution of identified issues during clinical data review cross-functionally and with clinical study sites in collaboration with the Clinical Trial team
- LI-DM1
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Director, Clinical Development Resume Examples & Samples
- Serve as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance
- Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports. Responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical oncology
- Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products
- Provide leadership on cross-functional product development team(s) as experience allows
- Participate in identification, selection and conduct of negotiations with clinical research centers and investigators
- Participate in the selection and management activities of CROs
- Supervise project team members in planning, conducting and evaluating clinical trials. Oversee planning and management of investigator meetings, advisory boards and other scientific committees
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Associate Director, Clinical Development Resume Examples & Samples
- Devise strategy for development and implementation of clinical studies for both investigational medicines and new indications for approved medicines
- Serve as medical resource for clinical issues raised by internal and external collaborators, investigators, consultants, business development and investor contacts
- Pharmaceutical development experience, preferably in hematology/oncology, or completion of specialty certification in hematology/oncology
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Associate Director Clinical Development Resume Examples & Samples
- Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine / Clin Pharm; May act as Clinical study leader (CSL)
- Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation; Oversees recruitment and retention; establishes and implements contingency plans for shortfalls; Consults & recruits members for DSMB and/or adjudication committee setup
- Study outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data; Works with BD&O to ensure SAP update
- External collaboration: Consults with internal experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective communication between CRO / vendors / ARO
- Additional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due diligence activities
- MSC or MPH – 3 Years
- PharmD, or PhD – None
- MD or MD/PhD – None
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Senior Director, Clinical Development Resume Examples & Samples
- Serve as clinical leader on trials in sleep therapeutic area for existing and new clinical programs working with other clinical development leaders
- Develop and implement strategic clinical for investigational products for the Sleep TA
- Identify and interact with opinion leaders to integrate current clinical practice and guidelines into global clinical development plans including relevant industry developments
- Work with project team members, regulatory affairs and senior management to integrate competitive intelligence and regulatory strategy with the clinical strategic plan
- Develop phase II -IV clinical protocols and work closely with other functional areas within the R&D Departments (regulatory, clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
- Provide clinical input to Statistical Analysis Plan and assume responsibility for the clinical review and interpretation of the clinical trial data
- Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, etc) and review sections from other functional areas
- Develop strategy for and lead clinical advisory board meetings to obtain strategic input into clinical development programs
- Serve as lead clinical (and or medical) representative with regulatory agencies
- Provide strategic input on new product concepts, long-range strategic plans and licensing opportunities
- Provide leadership in collaborations with strategic partners
- Supervise and be accountable for the generation of and management of messaging in clinical program and regulatory submissions
- Accountable for success and implementation of the clinical development strategy
- Represent the company at scientific, industry, regulatory, advocacy and financial community meetings and presentations, as well as other public relations opportunities
- Work in conjunction with Drug Safety and Pharmacovigilance to insure timely reporting of safety signals to regulatory authorities
- MD, DO degree – psychiatrist, neurologist, sleep specialist, preferred but other physicians will be considered, particularly those with expertise in clinical development in neurology, sleep or psychiatry; U.S. Board Certification/Eligibility preferred
- 5 years of clinical development experience. Demonstrated scientific and therapeutic expertise
- Excellent written and verbal communications skills and ability to work in a collaborative team environment
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Medical Director, Clinical Development Resume Examples & Samples
- MD or MD/PhD
- Clinical oncology experience; Board certification in oncology or hematology preferred
- 2-5 years industry experience in oncology drug development preferred
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Director, Clinical Development Urology Resume Examples & Samples
- Core Team Lead (CTL)
- ClinicalScience Lead (CSL)
- Clinical Scientist (CS)
- Ensuring alignment between the Governance Board, Core Team and Sub‐teams
- Developing the projectmilestones with the Core team and seeking endorsement from the Governance Board on the Global Development Strategy, Stage Gates and other decisions requiring Governance Board endorsement
- Guiding the project through the defined Stage Gates
- Analyzing, managing project risks and proposing solutionsfor risk mitigation and resolving project/functional conflicts
- Managing, together with the ProjectManager, the projectbudget and timelines
- With the Project Manager and core project team members from Commercial, managing the valuation of the project
- Communicating any potential risks to the Governance Board co‐chairs and any relevant line functions in a timely manner
- If applicable, managing external partnerships and ensuring alignment and preparation for Joint Development Committee (JDC) meetings
- LI-GA1
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Senior Director, Clinical Development, Immuno Resume Examples & Samples
- Design and oversee implementation of early stage clinical projects (as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST))
- Prepare clinical development plans that integrate pre-clinical and early clinical findings to ensure cross-functional alignment throughout the early phases of clinical development
- Design scientifically/ clinically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan; present and defend protocols and clinical development plans at internal governance forums
- Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II studies, managing the process from protocol development, study execution (e.g., ensuring that Serious Adverse Events are properly reported on a global basis) thorough individual study report and integrated regulatory documentation
- Provide oversight and guidance for Product Development Team, Clinical Study Team, Clinical Trial Team, and Translational Science Sub-Team
- Present study updates with protocol adherence, interim results, and final headline data to senior management as required (with support from Data Management and Stats & Programming team)
- Prepare documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy)
- Lead cross-functional teams comprised of multidisciplinary professionals and clinical scientists with direct responsibility for leading the Clinical Development team and effective delivery of their assets
- Implement clinical R&D policies, SOPs and related directives
- Review potential in-licensing candidates and present recommendations to Senior Management groups
- Medical Doctor with specialty training and certification in Oncology with a valid medical license
- The ideal candidate will have a mastery of the drug development process in oncology, ideally immuno-oncology (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully
- At least 5 plus years’ experience in Oncology clinical research in the pharmaceutical industry related to the design and/or conduct of clinical studies in oncology and/or hematology
- Excellent oral and written communication skills; strong interpersonal and listening skills
- Results driven and able to achieve creative and sound outcomes
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment
- Ability to make sound and timely decisions; agile in learning and action oriented
- High level of emotional intelligence; able to deal with ambiguity
- Able to relate to varied level audiences across organization; able to build and lead effective teams and coach & develop team members; able to set priorities for team and maintain accountability; skilful in negotiating organizational boundaries and hierarchy; experience managing and developing others
- Able to balance scientific & business perspectives; able to delegate effectively; strategic thinker who can provide vision and purpose for teams; demonstrates managerial courage
- Immuno-therapy experience. Specifically, experience in developing an immuno-oncology drug from translational/pre-clinical through PoC; experience in late-stage oncology drug development and/or registration
- Leadership and direct managerial experience in leading small teams across multiple phases of oncology drug development
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Assoc Medical Director, Clinical Development Resume Examples & Samples
- Provide strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neurology disease areas with knowledge from the medical community around the world
- Execute an early stage development program in ALS
- Integrate the scientific rationale, regulatory and payor requirements, input and advice from medical and patient advocacy groups, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP)
- Contribute to the development of strategic initiatives and specified Business Development activities
- Industry experience in clinical development preferred, but not required for Associate Medical Directors
- Demonstrated strategic and critical thinking
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Assoc Medical Director, Clinical Development Resume Examples & Samples
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the late stage Clinical Development Plan (CDP)
- Three (3) to five (5) years of experience in clinical or laboratory research
- Understand and are able to put together and present analyses of data
- Flexible and able to work in a fast-paced, rapidly changing environment
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Associate Director, Clinical Development Resume Examples & Samples
- Clinical Program Lead (CPL)
- Scientific knowledge and experience in the relevant Therapeutic Area preferred
- Minimum 5 years of clinical/research experience in the pharmaceutical/device industry preferred
