Amylyx Pharmaceuticals

Medical Director

• Serve as the Clinical Pharmacology lead for assigned development programs from first-in-human studies through Phase 3 clinical trials
• Develop and execute program-specific clinical pharmacology strategies aligned with overall development objectives
• Provide scientific leadership for PK, PD, exposure-response, population PK, modeling and simulation activities
• Design and oversee clinical pharmacology studies, including protocol development, analysis plans, interpretation of results, and reporting
• Collaborate with cross-functional teams to integrate clinical pharmacology into broader development strategies
• Partner with Clinical Development physicians, statisticians, pharmacometricians, Regulatory Affairs, Biometrics, and Medical Writing to support program execution
• Interpret clinical pharmacology data and translate findings into clear scientific and regulatory recommendations
• Contribute to dose selection, dose optimization, labeling strategy, and benefit-risk assessments
• Support preparation of regulatory submission documents including INDs, briefing books, CTDs, clinical pharmacology summaries, and responses to health authority questions
• Participate in regulatory agency meetings as a clinical pharmacology subject matter expert
• Manage external CROs, consultants, and pharmacometric vendors supporting assigned programs
• Stay current on emerging clinical pharmacology methodologies, regulatory expectations, and industry best practices
• Contribute to scientific publications, presentations, and internal knowledge sharing
• Mentor junior scientists and provide technical guidance across project teams as appropriate

Senior Director, Clinical Pharmacology