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Senior Director, Safety Physician

Amylyx Pharmaceuticals
October 2, 2026
Full-time
Remote
Worldwide
Clinical Research and Development
Role: Senior Director, Safety Physician responsible for medical and scientific oversight of safety and benefit-risk assessments for Amylyx's investigational and commercial products in post-bariatric hypoglycemia, Wolfram syndrome, and ALS. Responsibilities: provide safety data evaluation across the product lifecycle, lead safety signal detection, contribute to regulatory submissions, develop risk management plans, and collaborate across Clinical Development, Regulatory, Medical Affairs, and Pharmacovigilance teams. Requirements: MD/DO with 10+ years in medicine, pharmaceutical/biotech drug safety, or pharmacovigilance; experience supporting clinical-stage development and regulatory interactions; strong understanding of global pharmacovigilance regulations and safety data analysis; excellent communication and cross-functional collaboration skills. High-Value: focus on safety assessment in clinical and post-marketing phases for biopharma innovative therapies targeting high-unmet-need rare diseases. Work setup: remote within the US, with periodic travel to Cambridge, MA, and compliance with state-specific employment restrictions.