Senior Director, Clinical Pharmacology

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Amylyx Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🏥 Healthcare

💼 Consulting

🛡️ Insurance

Healthcare • Consulting • Insurance

Amylyx Pharmaceuticals is a company dedicated to discovering and developing innovative treatments for diseases with high unmet needs. They focus on conditions such as Amyotrophic Lateral Sclerosis (ALS), Post-Bariatric Hypoglycemia (PBH), Wolfram Syndrome, and Progressive Supranuclear Palsy (PSP). Amylyx is committed to supporting patients and their loved ones, creating more moments of significance for them. They have recently acquired a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation and have shown positive results in clinical trials for Wolfram syndrome. The company emphasizes transparency, setting realistic expectations, and collaborating to make impactful changes in the treatment of neurodegenerative diseases.

📋 Description

• 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

• 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

• 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