Director, Clinical Development Job Description
Director, clinical development
provides medical and strategic leadership for programs that integrate the individual’s extensive knowledge in basic and clinical science, neuroscience, neurology, and input from the medical community around the world.
Director, Clinical Development Duties & Responsibilities
To write an effective director, clinical development job description, begin by listing detailed duties, responsibilities and expectations. We have included director, clinical development job description templates that you can modify and use.
Sample responsibilities for this position include:
Serves as CD liaison/point-of-contact for medical monitor inquiries from clinical operations, clinical research organizations (CROs), , collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
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)
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
Develop and provide input to research protocols for specific projects promoting the diagnostic offering in different therapeutic areas, the Janssen Diagnostics message and value
Research and develop protocol designs and clinical FDA submission strategies
Supervise clinical safety services outsourced to contract research organizations (CROs), independent contractors, and other vendors
Develop, review, and provide input to safety sections of clinical and regulatory documents, , Investigator’s brochures, protocols, IND annual reports
Provide Mentorship to more junior early clinical research staff
Collaboration with Clinical Operations colleagues, including reporting of designated or discovered information important to trial execution
Oversee the CRO in the management of issues related to conduct of Early Clinical Research
Director, Clinical Development Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director, Clinical Development
List any licenses or certifications required by the position: M.D, MD, NCCPA, BLS
Education for Director, Clinical Development
Typically a job would require a certain level of education.
Employers hiring for the director, 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 Medical, Science, Life Sciences, Healthcare, Oncology, Nursing, Education, Internal Medicine, Hematology, Medicine
Skills for Director, Clinical Development
Desired skills for director, clinical development include:
Basic and clinical science
Input from the medical community around the world
Neurology
GCP
Good Clinical Practice
Regulatory
Research
Statistics
Clinical operations
Protocol design
Desired experience for director, clinical development includes:
Experience in Phase 1 though Phase 3 preferred
Experience with Adaptive Designs, Modeling, and Simulations is required
Proficiency with statistical software such as SAS and R is required
Ability to influence, negotiate and communicate with both internal and external customers is required.Biostatistics
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
Within the Janssen Diagnostics organization this person will be in charge of the clinical strategy for the development of new assays their implementation
Director, Clinical Development Examples
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Director, Clinical Development Job Description
Job Description Example
Our innovative and growing company is looking for a director, 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 director, clinical development
- Overseeing the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
- Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, internal groups, including, research, CMC, operations, legal and business development
- Design and plan the over-all scientific package (literature, pre-clinical, clinical, ) 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
- Responsible for the execution of assigned clinical trials in the US
- Manages and drives clinical study timelines with cross-functional teams, CRO's and business partners to ensure deliverables are met on schedule
- Trains and lends expertise to staff who serve on Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (i.e., Clinical Development Plan) and study deliverables with full consideration of contingencies and alternative approaches
- Manages two levels of Medical and Scientific Directors (typically 2 to 4 direct
- In rare circumstances, may lead a CST for an unusually complex, high-priority program
- Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the therapeutic area, directing appropriate scientific activities with internal stakeholders as they relate to ongoing projects
- Acts as a senior-level liaison for opinion leader interactions related to the disease area(s)
Qualifications for director, clinical development
- Ability to manage resources and budgets in a matrix organization and provide functional leadership
- Fluency in English, knowledge of major languages is a plus
- Minimum six (6) years performing progressively advanced duties and relevant work experience
- Master’s degree (e.g., MBA, MHA)
- Demonstrated 8-15 years of extensive, progressively responsible experience in a robust (public or private University-based) academic medical center
- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D
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Director, Clinical Development Job Description
Job Description Example
Our innovative and growing company is looking for a director, 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 director, clinical development
- Provide direct oversight and management of any contract based or full-time employees engaged in the task of Clinical study management and Monitoring
- Engage clinical trial sites to evaluate and develop opportunities to optimize participation, enrolment and conduct of clinical studies
- Maintain command of latest scientific data relevant to the role, knowledge of assigned study protocols related compliance and policy and procedure information
- Engage Key Medical Experts as needed to fulfil objectives of the Early Clinical development program
- Acts as a scientific resource for clinical trial sites and Key Medical Experts within assigned geography
- Respond to unsolicited medical inquiries regarding study drug and related trial issues as appropriate
- Attends medical conferences where applicable to collect and report relevant competitive intelligence
- Frequent travel (including occasional weekends) with overnight trips as necessary to accomplish above objectives
- Ensure clear communication with the Clinical Trial Management and other Clinical Trials operations personnel related to on-going issues around the conduct of the Early clinical studies outside the US
- Responsible for ongoing review of all study documents (IB, protocol amendments)
Qualifications for director, clinical development
- MD or PhD, with specialty training in psychiatry, neuroscience, or related fields required
- Experience in oncology, or central Nervous system preferred
- Pharmacovigilance, Drug Safety
- 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
- Strong project planning, leadership, negotiation and presentation skills ability to contribute creative yet practical solutions to problems
- Oversee clinical studies in collaboration with the cross functional clinical development teams
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Director, Clinical Development Job Description
Job Description Example
Our innovative and growing company is looking for a director, clinical development. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, clinical development
- The Clinical Lead may also serve as a Submission team leader or co-leader for regulatory submissions
- The Global Project Leader may also lead Agency interactions in partnership with the TA Head and Regulatory Affairs
- Designing of Clinical development program (CDP), execution and reporting of trials
- Monitoring safety of clinical trials and providing scientific leadership in the area of responsibility
- Providing scientific & clinical leadership of Phase 2 and 3 clinical trial teams
- Leading the development of the Integrated Study Plans and study summaries, IND submissions, and technical reports
- Providing input to strategic decisions regarding therapeutic indications
- Presenting data and scientific information to the organization at all levels
- Building credible relationships with opinion leaders and external alliances for partnered products when relevant
- Line management accountability for promotions, recruitment strategy and team structure
Qualifications for director, clinical development
- Design, initiation, enrollment and analysis of clinical studies
- Prepare clinical study protocols and perform medical monitor duties
- Work with Medical team in CRO and oversee medical conduct of clinical studies
- Establish appropriately clinical development timelines, incorporating key decision points and Go/No Go criteria for CDP
- Collegially lead strategic initiatives and clinical program teams
- 25% global travel is expected
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Director, Clinical Development Job Description
Job Description Example
Our company is hiring for a director, 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 director, clinical development
- May evaluate in-licensing opportunities and contribute to early development programs
- Expert for early first in human/Phase 1 clinical development matters on several cross-functional teams, incl
- Identifies, evaluates, actively pursues and closes new business opportunities-customer or product
- Cultivate relationships with current client base and pro-actively manage partnerships to maintain and grow existing business
- Monitor existing customer contracts and execute renewals with revised terms consistent with Niche Diagnostics objectives (as applicable) or execute terminations as applicable
- Field and manage all potential customer inquiries with timely response and feasibility evaluation
- Identification and pursuit of potential partners (scouting) based on up-to-date knowledge of diagnostic industry and trends aligning with Niche Diagnostics competencies and strategic goals/interests
- Develop a pipeline of qualified leads and new business opportunities capitalizing on Niche Diagnostics’ core competencies
- Conduct the necessary diligence within the organization and perform business case justification to determine the merits and prioritization
- Manage quotation process and ensure all RFQ deadlines are met
Qualifications for director, clinical development
- A recognized expert in the development of oncologic immune-based therapies, with outstanding scientific and leadership ability
- Experience authoring regulatory documents for immune-based cancer therapies is required
- Healthcare / scientific professional possessing therapeutic experience and/or trial recruitment experience
- Doctoral level degree (MD, PhD, PharmD, ) preferred
- Five or more years of relevant experience in the biotechnology or pharmaceutical industry or clinical setting experience such as drug information, disease management programs, clinical pharmacy, or clinical medicine
- Disease specific therapeutic area experience and knowledge required
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Director, Clinical Development Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, 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 director, clinical development
- Ensures frequent communication and timely and complete follow-up with current customers, leads, Perceived as the ‘go-to’ for customers within the CDD Niche Diagnostics organization
- Monitor and communicate industry trends relevant to strategic marketing and emerging business opportunities
- Prepare and deliver business/technical/capability presentations
- Schedules and coordinates quarterly business reviews with key customer accounts
- Key participant across the organization in the development and implementation of a strategic planning and prioritization process for projects undertaken by the organization
- Assist in the identification and marketing activities of new products
- Supports organization continuous improvement initiatives to maximize performance and improve process quality, efficiency, and effectiveness through benchmarking activities
- Provide Lean/Six Sigma expertise to project teams in Global Clinical Development Operations (GCDO), Lean Process Mapping
- The incumbent is an 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 submission documents
- In addition, the incumbent is the key contact for relationships to external experts/ key opinion leaders and provides regular scientific-medical disease state updates
Qualifications for director, clinical development
- Requires a Medical Degree
- Some travel within Takeda global sites may be required
- 15+ years of knowledge/experience in clinical drug development and trials process, attained within the pharmaceutical and/or CRO industry
- 10+ years of experience managing/leading teams/departments/divisions
- Experience analyzing and developing operational strategies
- Strategic ability to work closely with internal partners to build best practice solutions