Executive Director, Clinical Development

Job Title: Head of Clinical Development, Cardiovascular

Work Location: Suffolk County, Massachusetts

Summary:

This physician-only, cardiologist-specific leadership role is responsible for driving the clinical strategy and execution of cardiovascular development programs. The position involves medical leadership, clinical trial design, regulatory engagement, and cross-functional collaboration to advance clinical research and ensure compliance with regulatory standards.

Responsibilities:

• Develop and implement long-term clinical development strategies for cardiovascular programs, ensuring alignment with broader portfolio objectives.
• Lead the design, execution, and oversight of clinical trials, including protocol development, study conduct, and data interpretation.
• Provide medical leadership and scientific guidance to cross-functional teams throughout all phases of clinical development.
• Oversee safety data assessment, adverse event monitoring, and risk mitigation in collaboration with pharmacovigilance teams.
• Contribute to the preparation and review of regulatory submissions and represent clinical programs in interactions with health authorities.
• Collaborate with internal teams such as R&D, clinical operations, biostatistics, regulatory affairs, and commercial functions to achieve program goals.
• Engage with external stakeholders, including investigators, key opinion leaders, and scientific experts, to inform program direction and maintain relationships.
• Stay current on scientific advances, competitive intelligence, and therapeutic area trends to continuously refine clinical development strategies.

Qualifications:

• M.D. or D.O. required;
  Board Certification or eligibility in Cardiology is mandatory.
• Minimum of 10+ years of relevant experience in clinical research and drug development within academia, biotechnology, or the pharmaceutical industry.
• Proven track record in designing and executing clinical programs across multiple phases and geographic regions.
• Strong knowledge of GCP, ICH guidelines, global regulatory requirements, and the drug development process.
• Demonstrated leadership of cross-functional teams and experience engaging with regulatory agencies, investigators, and external partners.
• Excellent analytical, strategic, and communication skills.
• Experience authoring and reviewing clinical and regulatory documents, and contributing to global regulatory submissions and health authority interactions.