Senior Director, Clinical Pharmacology
Amylyx Pharmaceuticals
August 29, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Serve as Clinical Pharmacology lead for assigned programs from first-in-human through Phase 3.
- Develop and execute program-specific clinical pharmacology strategies aligned to development objectives.
- Lead PK/PD, exposure-response, population PK, and modeling & simulation activities.
- Design and oversee clinical pharmacology studies (protocols, analysis plans, interpretation, reporting).
- Integrate clinical pharmacology into cross-functional development plans.
- Partner with Clinical Development, Biometrics, Regulatory Affairs, Translational Medicine, Nonclinical, and Medical Writing to support execution.
- Translate clinical pharmacology data into scientific/regulatory recommendations.
- Support dose selection/optimization, labeling strategy, and benefit-risk assessments.
- Support regulatory submissions (INDs, briefing books, CTDs, clinical pharmacology summaries, health authority responses).
- Participate in regulatory agency meetings as SME.
- Manage external CROs/consultants and pharmacometrics vendors.
- Stay current on methodologies and best practices; contribute to publications/presentations.
- Mentor junior scientists and provide technical guidance.
Required Qualifications:
- PhD, PharmD, MD, or equivalent in Clinical Pharmacology/Pharmaceutical Sciences/PK/Pharmacometrics or related.
- 10–15+ years industry experience; at least 10 years direct Clinical Pharmacology.
- Experience across multiple clinical development stages.
- Desirable: biologics/peptides/small molecules/gene therapies.
- Experience preparing regulatory submissions and interacting with FDA/global authorities.
Preferred Qualifications:
- Strong PK/PD and clinical pharmacology strategy; population PK and exposure-response.
- Modeling/simulation familiarity; NONMEM, Phoenix WinNonlin, R, SAS, or comparable tools.
- Strong writing/presentation; interpret complex data and communicate recommendations.
- Project management; cross-functional collaboration; manage multiple programs; entrepreneurial mindset.
Estimated Pay Range: $268,000–$302,000 USD.
- Serve as Clinical Pharmacology lead for assigned programs from first-in-human through Phase 3.
- Develop and execute program-specific clinical pharmacology strategies aligned to development objectives.
- Lead PK/PD, exposure-response, population PK, and modeling & simulation activities.
- Design and oversee clinical pharmacology studies (protocols, analysis plans, interpretation, reporting).
- Integrate clinical pharmacology into cross-functional development plans.
- Partner with Clinical Development, Biometrics, Regulatory Affairs, Translational Medicine, Nonclinical, and Medical Writing to support execution.
- Translate clinical pharmacology data into scientific/regulatory recommendations.
- Support dose selection/optimization, labeling strategy, and benefit-risk assessments.
- Support regulatory submissions (INDs, briefing books, CTDs, clinical pharmacology summaries, health authority responses).
- Participate in regulatory agency meetings as SME.
- Manage external CROs/consultants and pharmacometrics vendors.
- Stay current on methodologies and best practices; contribute to publications/presentations.
- Mentor junior scientists and provide technical guidance.
Required Qualifications:
- PhD, PharmD, MD, or equivalent in Clinical Pharmacology/Pharmaceutical Sciences/PK/Pharmacometrics or related.
- 10–15+ years industry experience; at least 10 years direct Clinical Pharmacology.
- Experience across multiple clinical development stages.
- Desirable: biologics/peptides/small molecules/gene therapies.
- Experience preparing regulatory submissions and interacting with FDA/global authorities.
Preferred Qualifications:
- Strong PK/PD and clinical pharmacology strategy; population PK and exposure-response.
- Modeling/simulation familiarity; NONMEM, Phoenix WinNonlin, R, SAS, or comparable tools.
- Strong writing/presentation; interpret complex data and communicate recommendations.
- Project management; cross-functional collaboration; manage multiple programs; entrepreneurial mindset.
Estimated Pay Range: $268,000–$302,000 USD.