Senior Director, Clinical Systems
Philadelphia, Philadelphia County, Pennsylvania, 19117, USA
Listed on 2026-10-09
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IT/Tech
Information Security & Data Protection, Cybersecurity, Change Management
Role:
Senior Director, Clinical Systems at Amylyx, responsible for developing and optimizing clinical systems infrastructure to support expanding clinical development activities. Responsibilities include leading the implementation and management of Clinical Trial Management System (CTMS), establishing governance and standards for clinical platforms, and driving automation and AI initiatives to modernize clinical operations.
The role involves partnering with IT, Quality, Clinical Operations, and vendors to ensure system compliance, data integrity, and effective study support, while managing change and building the Clinical Systems team.
Qualifications:
Bachelor's in life sciences, information systems, or related; 15+ years in clinical operations, clinical systems, or biotech/pharma tech; expertise with clinical platforms such as CTMS, Veeva Vault, or Medidata Rave; knowledge of GxP, 21 CFR Part 11, ICH guidelines; strong project and change management skills.
High-Value:
Focus on clinical trial technology within biopharma, supporting clinical phases, regulatory compliance, and data-driven decision-making, with remote work preferred and periodic travel to Cambridge, MA.
The role demands strategic thinking and hands-
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