Senior Director, Clinical Pharmacology

The role

The Senior Director, Clinical Pharmacology provides strategic scientific leadership across multiple development programs from Phase 1 through Phase 3. This individual will develop and execute clinical pharmacology strategies to support regulatory submissions and drug development.

What you will do

• 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.
• 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.
• Interpret clinical pharmacology data and translate findings into 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, and clinical pharmacology summaries.
• Manage external CROs, consultants, and pharmacometric vendors.

Required qualifications

• 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.

Nice to have

• Experience with biologics, peptides, small molecules, or gene therapies is desirable.
• 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.

Benefits

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

Before you apply

• Unable to hire employees who reside and/or work in Alaska and Hawaii.
• Must have access to a work setting that enables meeting all role requirements including privacy, reliable internet, phone, and video conferencing.

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.