Director, IT R&D and Quality Applications
Amylyx Pharmaceuticals
September 03, 2026
Full-time
Remote
Worldwide
IT
Role: Director of IT R&D and Quality Applications, responsible for strategic management and lifecycle oversight of systems supporting research, clinical development, data management, biometrics, regulatory, pharmacovigilance, and quality functions in a clinical-stage biopharma. Core responsibilities include leading IT partnerships across Clinical Operations, supporting complex clinical trials (including decentralized models and connected devices), implementing R&D systems like CTMS, EDC, eTMF, and enabling AI solutions; developing data integration strategies; ensuring GxP compliance (ICH E6(R3), 21 CFR Part 11); managing vendor selection, system roadmaps, and budgets.
Qualifications required: Bachelor’s degree in Computer Science, Life Sciences, or related field; 10+ years in life sciences IT applications, with 5+ years supporting R&D/clinical systems; extensive experience with clinical trial systems and clinical data management platforms (preferably Veeva Vault R&D Suite); deep knowledge of GxP regulations and CDISC standards; strong vendor management and cross-functional team leadership skills.
Preferred skills: Expertise in integrating clinical data (wearables, medical devices), experience with Biometric platforms, and SaaS solutions.
High-value biopharma specifics include focus on clinical systems supporting complex trials, regulatory submissions, pharmacovigilance, and quality assurance, with an emphasis on compliance and data integrity.
Work setup: Remote work within select U.S. states with occasional travel to Cambridge, MA, for in-person meetings and company events.
Qualifications required: Bachelor’s degree in Computer Science, Life Sciences, or related field; 10+ years in life sciences IT applications, with 5+ years supporting R&D/clinical systems; extensive experience with clinical trial systems and clinical data management platforms (preferably Veeva Vault R&D Suite); deep knowledge of GxP regulations and CDISC standards; strong vendor management and cross-functional team leadership skills.
Preferred skills: Expertise in integrating clinical data (wearables, medical devices), experience with Biometric platforms, and SaaS solutions.
High-value biopharma specifics include focus on clinical systems supporting complex trials, regulatory submissions, pharmacovigilance, and quality assurance, with an emphasis on compliance and data integrity.
Work setup: Remote work within select U.S. states with occasional travel to Cambridge, MA, for in-person meetings and company events.