Senior Director, Clinical Pharmacology

Amylyx Pharmaceuticals

Senior clinical pharmacology leader guiding Amylyx Pharmaceuticals’ therapies for high-unmet-need diseases. Leading PK/PD strategy, clinical studies, regulatory submissions, and cross-functional development from Phase 1 through Phase 3.

Posted 8/7/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $268,000 - $302,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Pharmacology with a strong focus on PK/PD principles, regulatory submissions, and cross-functional collaboration. Proven ability to lead clinical pharmacology strategies and mentor junior scientists in a fast-paced biotechnology environment.

Highest-signal resume keywords

Clinical Pharmacology LeadershipRegulatory Submission PreparationPopulation PK AnalysisPharmacometric ModelingCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical PharmacologyPharmacokineticsPharmacodynamicsExposure-Response AnalysisRegulatory AffairsDose OptimizationScientific WritingData InterpretationClinical Trial DesignProject Management

Soft Skills

CollaborationMentoringOrganizational SkillsCommunicationEntrepreneurial Mindset

Tools & Technologies

NONMEMPhoenix WinNonlinRSAS

Industry Keywords

Pharmaceutical IndustryBiotechnologyClinical DevelopmentFDA InteractionsBiologicsPeptidesSmall MoleculesGene Therapies

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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
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

Benefits

Comp & perks

Remote work opportunities within the United States
Travel to company-related events as necessary and requested
Equal Opportunity Employer
Accommodations available for candidates who require them in the selection process