Senior Director, Clinical Pharmacology

🕒 August 7

🏈 Alabama, California, +39 more states – Remote

🏈 Alabama – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🦌 Connecticut – Remote 🐊 Florida – Remote 🥔 Idaho – Remote 🌽 Illinois – Remote 🌾 Iowa – Remote 🌪️ Kansas – Remote 🐎 Kentucky – Remote ⚜️ Louisiana – Remote 🦞 Maine – Remote 🦬 Montana – Remote 🌾 Nebraska – Remote 🎰 Nevada – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🌾 North Dakota – Remote 🏈 Ohio – Remote 🌪️ Oklahoma – Remote 🌲 Oregon – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote ❄️ Minnesota – Remote 🎸 Mississippi – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote ⚓ Rhode Island – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ⛷️ Utah – Remote 🍁 Vermont – Remote ⚔️ Virginia – Remote ☕ Washington – Remote ⛰️ West Virginia – Remote 🧀 Wisconsin – Remote 🦬 Wyoming – Remote

💵 $268k - $302k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 44%

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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 Clinical Development, Biometrics, Regulatory Affairs, Translational Medicine, Nonclinical, Medical Writing, and external partners • 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 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 • Stay current on 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

🎯 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 • Ability to work remotely with privacy, reliable internet access, phone, and video conferencing capabilities • Must reside and/or work in an eligible United States state; applicants from Alaska, Arizona, Hawaii, Michigan, and Tennessee are not currently considered

🏖️ Benefits

• Remote work opportunities within the United States • Travel to the Cambridge, MA corporate location several times a year • Attendance at company-related events as necessary and requested • Equal Opportunity Employer • Accommodations available for candidates who require them during the selection process

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