Senior Director, Clinical Pharmacology

Role: Senior Director, Clinical Pharmacology, providing strategic leadership from Phase 1 through Phase 3 for Amylyx's clinical programs targeting post-bariatric hypoglycemia, Wolfram syndrome, and ALS. Responsibilities: develop and execute clinical pharmacology strategies, oversee PK/PD modeling, exposure-response analyses, and study design; collaborate across functions (clinical, biometrics, regulatory, nonclinical, medical writing); support regulatory submissions, dose selection, and benefit-risk assessments; manage external vendors; mentor junior staff; contribute to scientific dissemination. Requirements: PhD/MD/PharmD in Clinical Pharmacology or related; 10–15+ years supporting clinical drug development, with deep expertise in PK/PD, modeling, and regulatory interactions; experience with biologics, peptides, small molecules, or gene therapies preferred. HighValue: support for biologics/small molecules, late-stage development (Phases 1-3), regulatory submissions, pharmacometric modeling, cross-functional leadership, and remote work with periodic travel to Cambridge, MA. WorkSetup: remote US-based (excluding certain states), with travel as needed.