Senior Director, Safety Physician

The role

The Senior Director, Safety Physician provides medical and scientific leadership for the safety profile and benefit-risk of investigational and commercial products. This person provides medical oversight of safety data throughout the product lifecycle.

What you will do

• Serve as the Safety Physician and medical safety lead for assigned products.
• Provide medical and scientific oversight of safety data across the product lifecycle.
• Lead or contribute to assessment of the overall safety profile and benefit-risk balance.
• Review and medically assess serious adverse events and other safety information.
• Provide medical oversight and guidance for case assessment.
• Lead or contribute to safety signal detection, validation, assessment, and monitoring.
• Identify emerging safety trends and provide recommendations for risk mitigation.
• Partner with Clinical Development on protocol development and safety monitoring materials.
• Provide safety expertise in the development and review of clinical study documents.
• Lead or contribute to the preparation of aggregate safety reports.

Required qualifications

• Medical degree (MD, DO, or international equivalent)
• Completion of postgraduate clinical training/residency
• 10+ years of relevant experience in medicine, pharmaceutical/biotechnology drug development, pharmacovigilance, or a combination of these areas
• 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
• Strong understanding of global pharmacovigilance regulations, standards, and practices
• Experience reviewing and interpreting clinical trial and post-marketing safety data
• Experience contributing to regulatory submissions and responding to health authority questions
• Ability to communicate complex medical and safety information to scientific and non-scientific audiences
• Strong cross-functional collaboration skills
• Ability to operate in a fast-paced, evolving biotechnology environment

Nice to have

• Board certification or equivalent specialty qualification
• Experience supporting late-stage development, regulatory submissions, product launch, and/or marketed products

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside in Alaska, Arizona, Hawaii, Michigan and Tennessee
• Must have access to a work setting that enables meeting all role requirements (privacy, reliable internet, phone, video conference)

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to usher in a new era for treating diseases with high unmet needs.