Director, Clinical Sciences – Rare Disease Trials

Amylyx Pharmaceuticals, Inc.

Cambridge (MA)

Remote

USD 214,000 - 241,000

Full time

2 days ago
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Job summary

Amylyx Pharmaceuticals, Inc. is seeking a Director of Clinical Sciences to lead scientific support across ongoing and upcoming clinical studies within the Clinical Development team.

The role reports to a Medical Director and collaborates across R&D, program management, clinical operations, biostatistics, and data management. The position requires a Master’s degree with 8+ years in drug development (MD/PhD/ PharmD preferred) and hands-on experience with Phase 1–III trials, GCP/ICH guidelines, and

Qualifications

  • Master’s Degree with 8+ years in drug development; advanced degree preferred.
  • Knowledge of Phase 1-3 drug development.
  • Clinical trial implementation and sponsor/site interactions.
  • Experience in endocrine, neurology or rare diseases.
  • Familiarity with GCP, ICH, FDA/EMEA guidance and regulations.
  • Strong team player with excellent attention to detail and communication.

Responsibilities

  • Collaborates with the clinical development team to review, analyze and interpret study results.
  • Provides scientific support for Phase I–III trials and helps design upcoming studies.
  • Performs monitoring of study data including labs, safety data, and eligibility.
  • Authors/reviews CTAs, protocols, CRFs, informed consent, deviations and monitoring plans.
  • Contributes to regulatory documents such as CSRs and IND/CTA sections.
  • Interacts with external medical advisors, thought leaders, and internal teams to execute the clinical development plan.

Skills

Phase 1-3 drug development
Clinical trial implementation
Sponsor/site interactions
Cross-functional collaboration
Attention to detail and communication

Education

Master’s degree in a relevant scientific or healthcare discipline
Advanced degree preferred (M.D./Ph.D./Pharm.D.)

Job description

Amylyx Pharmaceuticals, Inc. is seeking a Director of Clinical Sciences to lead scientific support across ongoing and upcoming clinical studies within the Clinical Development team.

The role reports to a Medical Director and collaborates across R&D, program management, clinical operations, biostatistics, and data management. The position requires a Master’s degree with 8+ years in drug development (MD/PhD/ PharmD preferred) and hands-on experience with Phase 1–III trials, GCP/ICH guidelines, and

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