Associate Director, Clinical Compliance & Records

Role: Associate Director, Clinical Compliance & Records, overseeing clinical trial compliance and TMF management for Amylyx's post-approval and early-phase studies in rare neurological and metabolic diseases. Responsibilities: ensure adherence to ICH-GCP, FDA, and SOPs; lead risk assessments, CAPAs, inspection readiness, and audit support; develop and maintain TMF strategies, including eTMF processes, documentation quality, and system migrations; collaborate with Clinical Operations, Quality, and Study Teams to drive process improvements. Requirements: Bachelor's in a health or science field; 8+ years in clinical compliance or TMF roles within pharma/biotech; strong knowledge of ICH-GCP, FDA guidelines, and TMF standards; proficiency with Veeva systems and MS Office. Preferred: experience supporting FDA/EMA inspections, TMF system administration. HighValue: focus on clinical compliance and TMF in early to late-phase studies, including post-market activities; experience with Veeva Clinical; working knowledge of inspection readiness; remote work within the U.S. with periodic travel to Cambridge, MA.