Job Title: Head of Clinical Development, Neuromuscular

Work Location: Suffolk County, Massachusetts

Summary:

The Head of Clinical Development, Neuromuscular is responsible for leading the clinical strategy and execution of neuromuscular disease development programs. This individual will provide medical leadership, guide cross-functional activities, and ensure compliance with regulatory requirements, contributing to study design, protocol development, data interpretation, and regulatory submissions.

Responsibilities:

• Develop and implement long-term clinical development strategies for neuromuscular disease programs, ensuring alignment with broader portfolio objectives.
• Lead the design and execution of clinical studies, including protocol development, amendments, and oversight of study conduct across multiple regions.
• Provide medical leadership and scientific guidance to cross-functional teams throughout all phases of clinical development.
• Oversee the assessment, interpretation, and reporting of safety data, collaborating closely with pharmacovigilance to ensure timely evaluation of safety information.
• Contribute to the preparation and review of regulatory submissions and represent clinical programs in interactions with health authorities.
• Partner with internal teams such as clinical operations, biostatistics, regulatory affairs, and medical affairs to support program objectives and decision-making.
• Engage with investigators, key opinion leaders, and external experts to inform program direction and maintain awareness of scientific and therapeutic trends.
• Support advisory boards, scientific congress activities, and external communications to advance the clinical development program.

Qualifications:

• M.D. or D.O. required.
• Significant clinical development experience in neuromuscular diseases strongly preferred (such as neuromuscular neurology, physiatry, or related specialty training).
• Minimum of 8–10+ years of relevant experience in clinical research and drug development within academia, biotechnology, or the pharmaceutical industry.
• Demonstrated experience 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.
• Proven 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.

Published Category: Clinical Operations & Development