Senior Director, Clinical Pharmacology

Amylyx Pharmaceuticals•Cambridge, MA

5d•Remote

About The Position

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity The Senior Director, Clinical Pharmacology is a highly experienced clinical pharmacologist who will provide strategic scientific leadership across multiple development programs from Phase 1 through Phase 3. Reporting to the Vice President, Clinical Pharmacology, this individual will partner with cross-functional program teams to develop and execute clinical pharmacology strategies that support regulatory submissions and successful drug development. This role will contribute deep expertise in pharmacokinetics (PK), pharmacodynamics (PD), exposure-response analyses, modeling and simulation, and clinical pharmacology study design. The successful candidate will work collaboratively with Clinical Development, Biometrics, Regulatory Affairs, Translational Medicine, Nonclinical, Medical Writing, and external partners to ensure robust clinical pharmacology strategies throughout development. As an experienced scientific leader, this individual will independently lead assigned programs while collaborating closely with the Vice President and other members of the Clinical Pharmacology team.

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.

Nice To Haves

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.
Entrepreneurial mindset with a willingness to contribute broadly across development programs.

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.