Clinical Development Job Description
Clinical development
provides clinical input to Statistical Analysis Plan and assume responsibility for the clinical review and interpretation of the clinical trial data.
Clinical Development Duties & Responsibilities
To write an effective clinical development job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical development job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensuring internal processes and Standard Operating Procedure (SOPs) are updated according to Good Clinical Practice (GCP) guidelines and ensures internal Quality Assurance standards and practices are in place
In conjunction with the Medical Director and other cross-functional representatives (e.g., Biometrics, Clinical Operations, CRO), coordinates the preparation, analysis and review of data outputs for reporting documents where appropriate
Contribute to overall study conduct and data validation with clinical operations (DM, CTM, Stat, Reg
Routinely interface with discovery, safety sciences, statistics, PK, pharmacovigilance
Develops, implements and evaluates programs to promote the recruitment, retention and continuing education of Sarah Cannon Innovations Clinical Operations staff
Manages the performance of all Sarah Cannon Innovations Clinical Operations colleagues, including role expectations and performance reviews
Reporting to the Global Clinical Development lead, the Clinical Development Physician will serve a key role of providing expert medical input to clinical development programs
Provide input into the Clinical Strategy (CDP)
May act as a company representative interacting with external scientific leaders and Regulatory authorities
Provide expe1t medical advice to the project teams for the development of Phase I-IV development programs
Clinical Development Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Development
List any licenses or certifications required by the position: EHR, NPD, PR, M.D, BLS, EP, CRT, SJM, MD
Education for Clinical Development
Typically a job would require a certain level of education.
Employers hiring for the clinical development job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Nursing, Health, Medical, Science, Life Sciences, Healthcare, Graduate, Engineering, Management
Skills for Clinical Development
Desired skills for clinical development include:
GCP
Clinical trial design
Statistics
ICH guidelines
Statistical analysis methodology
Clinical operations
Anatomy and surgical technique
Basic and clinical science
Good Clinical Practice
FDA requirements
Desired experience for clinical development includes:
Responsibilities will include design and supervision of Shire sponsored clinical trials, participation in medical interpretation of data analyses
Participate or co-lead prod uct safety review committees (SRT) as appropriate
Supervise external HCP educational courses, personally do field support/launch activities and co-operate with the field representatives to drive Clinical Strategy External Deployment
Work together with Clinical Trainer to ensure complete & timely delivery of internal clinical training and respective certification
Represent together with Clinical Trainer and the others CDS/CDM the Clinical HUB within EMEA
Ability to travel (up to 80% of time, frequency may vary from several in a month to several in a week)
Clinical Development Examples
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Clinical Development Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical development. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical development
- Manages aggressive timelines
- Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of AEs, SAE and protocol deviations
- Help create budgets and progress reports
- Serve as a Clinical Science representative on cross-functional teams as assigned, , Protocol Execution Team, Safety Sub-Team, Biomarker Sub-Team, cross-functional initiatives
- In conjunction with the Medical Director, create and or review presentations for internal and external meetings (e.g., Investigator meetings, pre-study site selection visits (PSSV) and site initiation visits (SIVs), Study Coordinator and CRA training, Advisory Boards, and internal and external medical/scientific meetings)
- Works with business development to identify and select consultants, vendors, contract research organizations (CROs)
- Assist in the conduct of study site initiation visits (preparation, personnel training, ) and study start-up + close-out meetings, global investigator meetings (preparation of the scientific and medical communication)
- Ensure partnerships are implemented according to ethical/regulatory/legal requirements
- Review/contribute and author presentations, medical publications, posters, emerging from the team and its affiliates
- Works on new initiatives and special projects as directed by President, Sarah Cannon Development Innovations / Sr
Qualifications for clinical development
- Strong team player, conflict resolution skillsMarketing
- Collaborate with stakeholders across the company (product, legal, finance, sales, marketing, oncology, ) to properly identify, prioritize, and execute on cross-industry collaboration/partnership opportunities
- Lead all aspects of deal execution, including identification and prioritization of partners, strategic and financial assessment, transaction structuring and negotiation, follow through to results, and relationship management
- You understand the common challenges faced by healthcare providers and life sciences firms related to clinical trials and have experience solving these problems
- You have robust project management skills with demonstrated success in bringing highly complex, cross-functional projects to completion
- You have exceptional written and communication skills and experience developing high profile external relationships
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Clinical Development Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical development. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical development
- Tracking and managing high-level trial milestones
- Forecasting and managing resources across and within trials
- Overseeing collection and management of clinical trial data
- Facilitating communication on all trial matters
- Assists in developing study budgets, contracts and agreements
- Assists in developing and executing Sarah Cannon internal and external strategies
- Assists in completion of all RFP bids for Innovations
- Informs President, Innovations of issues, progress, and risks related to trial operations
- Directs and oversees Project Management department
- Directs and oversees Monitoring department
Qualifications for clinical development
- You have a high degree of comfort with ambiguity - you’re able to quickly develop hypotheses with limited information and have a demonstrated ability to learn complex concepts quickly
- You have a nose for value - you’re able to effectively prioritize and think strategically in a challenging, rapidly changing, and time sensitive environment
- You’re a highly analytical, strategic thinker with the ability to translate between strategic business decisions and their implications
- You’re passionate about our mission to improve healthcare through technology
- Must be knowledgeable of nursing and medical practices and procedures, laws, regulations and guidelines that pertain to nursing care facilities
- Highly collaborative, self-starter
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Clinical Development Job Description
Job Description Example
Our growing company is hiring for a clinical development. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical development
- Directs and oversees Study Activation department
- Evaluates organizational processes associated with trial execution and identifies ways to improve and streamline internal procedures
- Ensures appropriate resources are available to meet corporate, sponsor and project objectives while achieving optimal utilization of staff
- Oversees and assigns relevant tasks to both internal and external team members
- Planning and facilitating meetings and committees to address departmental issues and cross divisional communication within Sarah Cannon
- Presenting data at external forums as necessary
- Attending, managing and/or participating in all required meetings including Directors meeting
- Working with Business Development as a spokesperson for the Sarah Cannon Innovations division
- Manages timelines
- Oversee operational activities and personnel including clinical research, drug safety and biostatistics
Qualifications for clinical development
- Talent to become a trusted and valued opinion leader among non-subordinating team members
- Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system
- A doctoral degree (PhD/MD/PharmD) in scientific or life sciences field
- Industry experience within in vitro diagnostics (IVD) highly preferred
- Supervisory and team leadership skills highly desirable
- Board certification highly preferred
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Clinical Development Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical development. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical development
- Design, implement and facilitate annual market development plan for CMD continuous growth in clinical diagnostics
- Organize and participate marketing activities, such as seminars, workshops and collaboration with customers
- Design and support training activities in clinical application, including product and application training
- Organize and implement key account programs
- Liaison with factory marketing team to keep them informed of the China market dynamics for CMD products, delivering the latest product information and to sales team
- Provide technical assistance, consultation and problem-solving solutions to sales/customers as necessary
- Management of ongoing site alliances
- Understand key business drivers
- Assist team with study start up activities for the BOTOX Instillation Study, eg pharmacy manual, investigator meeting materials
- Review and modify clinical and claim substantiation study protocols
Qualifications for clinical development
- Minimum of 10 years of Pharmaceutical/Medical Device industry experience
- At least 6 years of monitoring and/or site development experience
- Previous leadership, training, and/or sales or marketing experience is desirable and may substitute for monitoring experience
- Requires strong MS Office skills, including MS Project, Excel, Word and an in-depth knowledge of MS PowerPoint
- Able to work a standard work schedule of 8am-5pm Monday-Friday (and additional hours as required)
- Familiarity with technical terminology a plus
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Clinical Development Job Description
Job Description Example
Our growing company is looking to fill the role of clinical development. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical development
- Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs and Commercial teams
- Responsible for managing calendar, scheduling meetings, making travel arrangements, preparing expense reports
- Development and upkeep of general Excel files, Word documents and PowerPoint presentations
- Contributes to and reviews clinical science trial related documents documents generated by other departments (Statistic, Operation, Data Management )
- Working with the team to implement the clinical protocol development process in collaboration with other members of the development team, and Safety Department
- Responsible author for clinical synopsis, outline, protocols, amendments and related documents
- Contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions
- First point of contact within Halozyme for the investigational study sites with regard to questions about patient eligibility in trials, protocol waivers, safety issues, regular review of safety parameters and generation of periodic safety reports, and the receipt and processing of SAEs, including review of narratives for SAEs and participation in IND expedited safety reporting
- Will coordinate real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, and biomarker data to provide consolidated information for dose escalation meetings and data reviews with investigators
- Serve as the external clinical “face” of the program in interactions with development partners, and leading clinical discussions at investigator meetings
Qualifications for clinical development
- A PharmD, PhD is required
- A minimum of five to seven years progressive experience in pharmaceutical, biopharmaceutical or biotechnology drug development is required
- Working knowledge of scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities
- A higher qualification
- Medical degree with Board Certification/Specialty background, or equivalent status, in a relevant area (Pediatrics, Neurology, Transplantation or similar)
- Regulatory/global health authority interactions, including reviewing and responding to regulatory agency queries developing medical sections of relevant regulatory documents