Note: The job is a remote job and is open to candidates in USA. Amylyx Pharmaceuticals is hiring a Senior Director, Clinical Pharmacology to provide strategic scientific leadership across clinical development programs from Phase 1 through Phase 3. The role leads clinical pharmacology strategy and studies, interprets PK/PD and related data, supports regulatory submissions, and collaborates with cross-functional teams.

Responsibilities

• 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

Skills

• PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, or a related scientific discipline
• Approximately 10–15+ years of pharmaceutical or biotechnology industry experience, including significant experience supporting clinical drug development
• At least 10 years of direct experience in Clinical Pharmacology
• Experience supporting multiple clinical development stages, including early and late-stage development
• Experience preparing regulatory submissions and interacting with FDA and other global health authorities
• Strong understanding of PK/PD principles and clinical pharmacology strategy
• Experience with population PK and exposure-response analyses
• Familiarity with pharmacometric modeling and simulation approaches
• Working knowledge of NONMEM, Phoenix WinNonlin, R, SAS, or comparable clinical pharmacology software
• Excellent scientific writing and presentation skills
• Ability to independently interpret complex clinical data and communicate recommendations to senior leadership
• Strong project management and organizational skills
• Demonstrated success working in highly collaborative, cross-functional environments
• Ability to manage multiple programs simultaneously in a fast-paced biotechnology environment
• Entrepreneurial mindset with a willingness to contribute broadly across development programs
• Experience with biologics, peptides, small molecules, or gene therapies is desirable

Benefits

• Remote work opportunities within the United States, except applicants residing and/or working in Alaska, Arizona, Hawaii, Michigan, and Tennessee; travel to the Cambridge, MA corporate location several times a year and other company-related events as requested.

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