Demo

Medical Director, Clinical Development

Leading Age
Boston, MA Full Time
POSTED ON 4/12/2025
AVAILABLE BEFORE 5/11/2025

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

  • Education & Experience
  • M.D. or M.D. / Ph.D. from an accredited institution; board certification or eligibility in a relevant specialty (cardiology, endocrinology, etc.) preferred.

  • At least 5 years of relevant experience.
  • A minimum of 1 year of experience overseeing the execution of clinical trials, preferably within an industry setting.
  • Experience in developing and reviewing clinical documents, including study protocols, informed consent documents, and investigator’s brochures.
  • Skills & Abilities
  • Strong knowledge of clinical trial design, regulatory requirements, GCP guidelines, and industry best practices.

  • Proven ability to interpret clinical trial data, including safety assessments and efficacy endpoints, and apply it to inform decision-making.
  • Leadership skills with the ability to collaborate effectively with cross-functional teams and external stakeholders.
  • Excellent communication and presentation skills, with the ability to represent the company at scientific conferences, advisory boards, and regulatory meetings.
  • Ability to develop relationships with key opinion leaders (KOLs), clinical investigators, and contract research organizations (CROs).
  • Familiarity with translational biomarker strategies and integration of early-phase data into clinical development plans is a plus.
  • Ability to travel to clinical sites, conferences, and regulatory meetings as needed.
  • Collaborative mindset, fostering innovation, scientific rigor, and high performance in a team setting.
  • Strong problem-solving skills with the ability to resolve trial-related issues and ensure smooth execution.
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