What are the responsibilities and job description for the Medical Director, Clinical Development position at Leading Age?
The Position
Verve is seeking a Medical Director, Clinical Development to lead the clinical trial efforts for our innovative gene editing therapies targeting cardiovascular disease. In this key role, you will provide medical oversight and strategic leadership throughout the trial lifecycle, ensuring scientific integrity, regulatory compliance, and patient safety. You will collaborate with cross-functional teams, contribute to regulatory submissions, and help implement biomarker strategies. Reporting to the Vice President of Translational Medicine, this high-visibility position offers the opportunity to drive clinical development and engage with key external stakeholders. The ideal candidate will excel in a fast-paced, dynamic environment and possess strong communication and attention to detail.
Job Responsibilities
- Provide medical oversight and strategic leadership throughout the clinical trial lifecycle, including the design, planning, execution, and interpretation of trials for investigational compounds, ensuring patient safety and scientific integrity.
- Contribute to the design and development of key clinical documents, including study protocols, investigator’s brochures, informed consent documents, and other essential materials.
- Ensure the clinical development strategy adheres to industry best practices and regulatory guidelines while collaborating with study investigators and medical experts in the development and execution of study protocols.
- Lead the review and interpretation of clinical trial data, including safety assessments, efficacy endpoints, and overall trial progress.
- Serve as a key medical expert in cross-functional discussions, including regulatory submissions, investigator meetings, and advisory boards.
- Work with the Clinical Operations team to identify and resolve trial-related issues, ensuring smooth execution and compliance.
- Collaborate closely with the clinical operations, regulatory, and data management teams to ensure timely and high-quality execution of clinical trials.
- Collaborate with the research team to develop and implement a translational biomarker strategy for the program integrating early-phase data to inform clinical strategy.
- Contribute to regulatory submission efforts by providing clinical insight into IND submissions, clinical trial applications, and other regulatory documents support responses to health authorities and ethics committees.
- Represent the company at scientific conferences, advisory boards, and meetings with regulatory authorities.
- Develop and maintain relationships with external stakeholders, including key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs).
- Foster a collaborative and positive team environment that encourages innovation, scientific rigor, and high-performance standards.
- Travel to clinical sites, conferences, and regulatory meetings as needed.
- Other duties as assigned.
Qualifications
M.D. or M.D. / Ph.D. from an accredited institution; board certification or eligibility in a relevant specialty (cardiology, endocrinology, etc.) preferred.
Strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices.
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