Senior Director, Safety Physician

amylyx; Cambridge (MA); On-site; USD 250,000 - 300,000; Full time

Job summary

Amylyx is seeking a Senior Director, Safety Physician to provide medical and scientific leadership for safety evaluation across investigational and commercial products.

Reporting to the Vice President, Patient Safety and Pharmacovigilance, the Senior Director will partner closely with colleagues in Clinical Development, Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics, and other functions.

Responsibilities

• Provide medical safety oversight across the product lifecycle, from development through post-marketing surveillance.
• Lead safety signal detection, assessment, and risk mitigation activities with cross-functional teams.
• Collaborate on regulatory submissions, safety sections, and associated clinical study documents.

Skills

Medical degree

Pharmacovigilance expertise

Regulatory knowledge

Job description

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

The Senior Director, Safety Physician is a key member of the Patient Safety and Pharmacovigilance organization and will provide medical and scientific leadership for the ongoing evaluation of the safety profile and benefit-risk of Amylyx investigational and commercial products.

Reporting to the Vice President, Patient Safety and Pharmacovigilance, the Senior Director, Safety Physician will serve as a medical safety expert across assigned programs and products, partnering closely with colleagues across Clinical Development, Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics, and other functions.

This individual will provide medical oversight of safety data throughout the product lifecycle, including clinical development, regulatory submission and review, product launch, and post-marketing surveillance. The successful candidate will bring strong clinical judgment, pharmacovigilance expertise, and the ability to translate complex safety information into clear assessments and recommendations for internal teams, senior leadership, health authorities, and other stakeholders.

Responsibilities

• Serve as the Safety Physician and medical safety lead for assigned investigational and/or commercial products.
• Provide medical and scientific oversight of safety data across the product lifecycle, from early clinical development through post-marketing surveillance.
• Lead and/or contribute to ongoing assessment of the overall safety profile and benefit-risk balance of assigned products.
• Review and medically assess serious adverse events, adverse events of special interest, suspected unexpected serious adverse reactions, and other clinically significant safety information.
• Provide medical oversight and guidance for case assessment, including seriousness, expectedness, causality, clinical significance, and appropriate follow-up.
• Lead or contribute to safety signal detection, validation, assessment, prioritization, and ongoing monitoring activities.
• Identify emerging safety trends and provide medically sound recommendations regarding potential risk mitigation or additional evaluation.
• Partner with Clinical Development and study teams on protocol development, safety monitoring strategy, safety monitoring plans, protocol development, informed consent documents, investigator brochures, and other clinical development materials.
• Provide safety expertise in the development and review of clinical study documents, including protocols, clinical study reports, integrated safety summaries, and regulatory submission materials.
• Lead or contribute to the preparation and medical review of aggregate safety reports, including DSURs, PBRERs/PSURs, and other required periodic safety reports.
• Support the development, maintenance, and implementation of Risk Management Plans, REMS or other risk-minimization activities, as applicable.
• Provide medical safety expertise for regulatory submissions, health authority questions, information requests, inspections, and other regulatory interactions.
• Participate in and present safety assessments and recommendations to internal safety governance committees and other cross-functional decision-making forums.
• Collaborate closely with Regulatory Affairs on safety-related labeling, including the development and maintenance of appropriate safety language.
• Partner with Medical Affairs and Commercial colleagues, as appropriate, to support medical safety activities associated with product launch and post-marketing surveillance while maintaining appropriate pharmacovigilance independence.
• Provide medical input into pharmacovigilance agreements and safety considerations associated with partnerships, licensing arrangements, or other business development activities, as needed.
• Work closely with PV Operations, contractors, and external vendors to ensure high-quality and timely execution of pharmacovigilance activities.
• Contribute to the development and continuous improvement of pharmacovigilance processes, procedures, systems, and infrastructure as the organization and portfolio grow.
• Maintain current knowledge of global pharmacovigilance regulations, guidanc