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. #J-18808-Ljbffr