Senior Director, Safety Physician

Amylyx Pharmaceuticals, Inc.; United States; Sur place; USD 250 000 - 320 000; Plein temps

Résumé du poste

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.

Remote within the US with periodic travel to Cambridge, MA; drive safety data evaluation and risk management across the product lifecycle in collaboration with Clinical Development, Regulatory, Medical Affairs and Pharmacovigilance teams.

Qualifications

• MD/DO with 10+ years in medicine or pharmacovigilance.
• Experience supporting clinical-stage development.
• Knowledge of global pharmacovigilance regulations.
• Excellent communication and cross-functional collaboration.

Responsabilités

• Provide safety data evaluation across the product lifecycle.
• Lead safety signal detection.
• Contribute to regulatory submissions.
• Develop risk management plans.
• Collaborate with Clinical Development, Regulatory, Medical Affairs and Pharmacovigilance teams.

Connaissances

Pharmacovigilance

Regulatory interactions

Safety data analysis

Cross-functional collaboration

Communication skills

Formation

MD/DO

Description du poste

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.