Senior Director, Clinical Pharmacology
Amylyx Pharmaceuticals
August 07, 2026
Remote
United States
Clinical Research and Development
Anticipated hire: September 2026
Responsibilities:
- Serve as Clinical Pharmacology lead for assigned development programs from first-in-human through Phase 3.
- Develop and execute program-specific clinical pharmacology strategies aligned with development objectives.
- Provide scientific leadership for 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 broader development strategies with cross-functional teams.
- Partner with Clinical Development, Biometrics, Regulatory Affairs, Translational Medicine, Nonclinical, Medical Writing, statisticians, and pharmacometricians to support execution.
- Interpret clinical pharmacology data and translate 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 a clinical pharmacology SME.
- Manage external CROs, consultants, and pharmacometrics vendors.
- Stay current on methodologies, regulatory expectations, and industry best practices; contribute to publications/presentations.
- Mentor junior scientists.
Required Qualifications:
- PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology/Pharmaceutical Sciences/PK/Pharmacometrics or related field.
- 10–15+ years industry experience supporting clinical drug development; at least 10 years direct Clinical Pharmacology experience.
- Experience across early and late-stage clinical development.
- Desirable: biologics/peptides/small molecules/gene therapies.
- Experience preparing regulatory submissions and interacting with FDA/global health authorities.
Preferred Qualifications (skills):
- Strong PK/PD and clinical pharmacology strategy knowledge; population PK and exposure-response experience.
- Familiarity with pharmacometric modeling/simulation; working knowledge of NONMEM, Phoenix WinNonlin, R, SAS (or comparable tools).
- Excellent scientific writing/presentation; interpret complex data and communicate to senior leadership.
- Strong project management; success in cross-functional environments; ability to manage multiple programs.
- Entrepreneurial mindset.
Work location/conditions:
- Remote (US) with some travel to Cambridge, MA several times/year.
Compensation (estimate):
- $268,000–$302,000 USD.
Application instructions:
- Apply through the company website (link provided).
Responsibilities:
- Serve as Clinical Pharmacology lead for assigned development programs from first-in-human through Phase 3.
- Develop and execute program-specific clinical pharmacology strategies aligned with development objectives.
- Provide scientific leadership for 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 broader development strategies with cross-functional teams.
- Partner with Clinical Development, Biometrics, Regulatory Affairs, Translational Medicine, Nonclinical, Medical Writing, statisticians, and pharmacometricians to support execution.
- Interpret clinical pharmacology data and translate 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 a clinical pharmacology SME.
- Manage external CROs, consultants, and pharmacometrics vendors.
- Stay current on methodologies, regulatory expectations, and industry best practices; contribute to publications/presentations.
- Mentor junior scientists.
Required Qualifications:
- PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology/Pharmaceutical Sciences/PK/Pharmacometrics or related field.
- 10–15+ years industry experience supporting clinical drug development; at least 10 years direct Clinical Pharmacology experience.
- Experience across early and late-stage clinical development.
- Desirable: biologics/peptides/small molecules/gene therapies.
- Experience preparing regulatory submissions and interacting with FDA/global health authorities.
Preferred Qualifications (skills):
- Strong PK/PD and clinical pharmacology strategy knowledge; population PK and exposure-response experience.
- Familiarity with pharmacometric modeling/simulation; working knowledge of NONMEM, Phoenix WinNonlin, R, SAS (or comparable tools).
- Excellent scientific writing/presentation; interpret complex data and communicate to senior leadership.
- Strong project management; success in cross-functional environments; ability to manage multiple programs.
- Entrepreneurial mindset.
Work location/conditions:
- Remote (US) with some travel to Cambridge, MA several times/year.
Compensation (estimate):
- $268,000–$302,000 USD.
Application instructions:
- Apply through the company website (link provided).