Senior Director, Safety Physician

Amylyx Pharmaceuticals•Cambridge, MA

11h•$276,000 - $310,000•Remote

About The Position

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.

Requirements

Medical degree (MD, DO, or international equivalent) required.
Completion of postgraduate clinical training/residency; board certification or equivalent specialty qualification is preferred.
10+ years of relevant experience in medicine, pharmaceutical/biotechnology drug development, pharmacovigilance, or a combination of these areas, with significant experience providing medical oversight of drug safety activities.
Meaningful experience serving as a Safety Physician, Product Safety Lead, or similar medical safety role within the pharmaceutical or biotechnology industry.
Experience supporting clinical-stage development programs required; experience supporting late-stage development, regulatory submissions, product launch, and/or marketed products strongly preferred.
Strong understanding of global pharmacovigilance regulations, standards, and practices, including safety reporting, signal management, aggregate reporting, benefit-risk assessment, and risk management.
Experience reviewing and interpreting clinical trial and post-marketing safety data and integrating information from multiple sources to develop medically sound conclusions.
Experience contributing to regulatory submissions and responding to safety-related health authority questions.
Demonstrated ability to effectively communicate complex medical and safety information to both scientific and non-scientific audiences.
Strong cross-functional collaboration skills and the ability to influence decisions in a highly matrixed environment.
Ability to operate effectively in a fast-paced, evolving biotechnology environment and balance strategic thinking with hands-on execution.
Excellent written, verbal, analytical, and presentation skills.

Nice To Haves

Board certification or equivalent specialty qualification is preferred.

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, guidance, industry standards, and evolving safety science.
Foster a culture of patient-centered focus, scientific rigor, collaboration, accountability, and high-quality decision-making.