Senior Director, Clinical Sciences
Amylyx Pharmaceuticals
July 01, 2026
Remote
United States
Clinical Research and Development
The Senior Director, Clinical Sciences will be a key member of the Clinical Development team, responsible for providing scientific support for ongoing activities and supporting key development activities for clinical studies and overall execution of program Clinical Development Plans (CDP).
Responsibilities:
- Collaborate with the clinical development team to review, analyze, and interpret study results.
- Provide scientific support for ongoing Phase I–III clinical trials and help plan/design upcoming studies.
- Monitor and review study data (labs, safety, patient eligibility) and consult with the program physician as needed.
- Author and/or review clinical trial documents (protocols, CRF, informed consent, protocol deviations, monitoring plans, regulatory documents).
- Contribute to regulatory documents (CSRs, Investigator’s Brochures, Clinical sections of INDs/CTAs).
- Interact with external advisors/thought leaders/investigators and internal teams to prepare/revise/maintain and execute the clinical development plan.
Required Qualifications:
- Advanced degree (Ph.D., Pharm.D., or Master’s in a science/medical field); PhD or PharmD with 5+ years clinical research/pharma/CRO experience, OR Master’s with 10+ years relevant experience.
- Knowledge of Phase 1–3 drug development.
- Knowledge of clinical trial implementation and sponsor/site interactions.
- Working knowledge of GCP, ICH, FDA, EMEA, and other relevant regulations.
- Strong collaborative skills; excellent attention to detail and communication.
Preferred Requirements:
- Experience in rare disease within neurology or endocrinology.
Work Location/Conditions:
- Remote within the U.S.; travel to Cambridge, MA several times per year and attend events as requested; reliable internet/phone/video conferencing required.
Estimated Pay Range: $257,000–$289,000 USD.
Application instructions: Apply for the role.
Responsibilities:
- Collaborate with the clinical development team to review, analyze, and interpret study results.
- Provide scientific support for ongoing Phase I–III clinical trials and help plan/design upcoming studies.
- Monitor and review study data (labs, safety, patient eligibility) and consult with the program physician as needed.
- Author and/or review clinical trial documents (protocols, CRF, informed consent, protocol deviations, monitoring plans, regulatory documents).
- Contribute to regulatory documents (CSRs, Investigator’s Brochures, Clinical sections of INDs/CTAs).
- Interact with external advisors/thought leaders/investigators and internal teams to prepare/revise/maintain and execute the clinical development plan.
Required Qualifications:
- Advanced degree (Ph.D., Pharm.D., or Master’s in a science/medical field); PhD or PharmD with 5+ years clinical research/pharma/CRO experience, OR Master’s with 10+ years relevant experience.
- Knowledge of Phase 1–3 drug development.
- Knowledge of clinical trial implementation and sponsor/site interactions.
- Working knowledge of GCP, ICH, FDA, EMEA, and other relevant regulations.
- Strong collaborative skills; excellent attention to detail and communication.
Preferred Requirements:
- Experience in rare disease within neurology or endocrinology.
Work Location/Conditions:
- Remote within the U.S.; travel to Cambridge, MA several times per year and attend events as requested; reliable internet/phone/video conferencing required.
Estimated Pay Range: $257,000–$289,000 USD.
Application instructions: Apply for the role.