Senior Director, Clinical Pharmacology

Amylyx Pharmaceuticals•Cambridge, MA

1d•$268,000 - $302,000•Remote

About The Position

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The Senior Director, Clinical Pharmacology will provide strategic scientific leadership across multiple development programs from Phase 1 through Phase 3. Reporting to the Vice President, Clinical Pharmacology, the role partners with cross-functional program teams to develop and execute clinical pharmacology strategies that support regulatory submissions and drug development. The position requires expertise in pharmacokinetics (PK), pharmacodynamics (PD), exposure-response analyses, modeling and simulation, and clinical pharmacology study design. The Senior Director will independently lead assigned programs while collaborating with the Vice President and Clinical Pharmacology team, as well as colleagues in Clinical Development, Biometrics, Regulatory Affairs, Translational Medicine, Nonclinical, Medical Writing, and external organizations. The role is remote within the United States, subject to state eligibility restrictions. Travel to the company’s Cambridge, Massachusetts corporate location several times a year and to other company events as needed is expected. The employee must have a remote work setting that supports privacy, reliable internet, telephone access, and video conferencing. Amylyx anticipates hiring in September 2026.

Requirements

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 and willingness to contribute broadly across development programs.

Nice To Haves

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

Responsibilities

Serve as Clinical Pharmacology lead for assigned development programs from first-in-human studies through Phase 3 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 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.