Director, Clinical Development Job Description
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:
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:
Desired experience for director, clinical development includes:
Director, Clinical Development Examples
Director, Clinical Development Job Description
- 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)
- 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
Director, Clinical Development Job Description
- 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)
- 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
Director, Clinical Development Job Description
- 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
- 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
Director, Clinical Development Job Description
- 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
- 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
Director, Clinical Development Job Description
- 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
- 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