Director, Drug Safety & Pharmacovigilance Scientist

Role: Provide strategic scientific leadership in drug safety and pharmacovigilance for Dyne's neuromuscular disease programs, including DMD and DM1, with preclinical efforts in FSHD and Pompe disease. Responsibilities: oversee safety surveillance, signal detection, benefit-risk assessment, and risk management across clinical and preclinical stages; contribute to safety reports, regulatory submissions, and safety governance; collaborate with cross-functional teams including Clinical Development, Regulatory, Medical Affairs, and Data Management; develop safety strategies, monitor compliance, and enhance pharmacovigilance processes. Requirements: advanced degree in life sciences or related field (MD, PharmD, PhD preferred); 10+ years in pharmacovigilance, drug safety, or clinical development within biotech/pharma; expertise in safety surveillance, signal evaluation, benefit-risk analysis, and global regulatory standards (FDA, EMA, ICH). HighValue: experience with clinical-stage biopharma, neuromuscular or rare diseases, biologics or gene therapies, safety data analysis, regulatory safety reporting, and vendor oversight. WorkSetup: based in Waltham, MA; no specific travel noted.