Director, IT R&D and Quality Applications
About The Position
Amylyx is looking for a Director, IT R&D and Quality Applications to foster strong functional partnerships and provide strategic technical support. In this role you will lead the strategy, delivery, and lifecycle management of systems supporting Research, Clinical Development, Data Management, Biometrics, Regulatory, Pharmacovigilance, and Quality functions. Additional responsibilities will include a range of activities within the information technology organization including project management, development, and maintaining procedures to ensure Amylyx has a stable, robust, and scalable set of applications to support the changing business needs and support. This role ensures the operation of scalable, compliant platforms supporting Amylyx’s product development pipeline including complex clinical trials and regulatory activities.
Requirements
- Bachelor’s degree in computer science, Life Sciences, or related field.
- 10+ years of Life sciences business applications experience with 5+ years implementing and supporting R&D / Clinical Systems.
- Experience with clinical trial systems is required (CTMS, eTMF, eCRO, ePRO).
- Deep expertise in Veeva Vault R&D Suite (Clinical, RIM, Quality, Safety)
- Expertise in integrating complex clinical data sources including ePRO, wearables, and medical devices.
- Strong knowledge of GxP regulations, CDISC standards (SDTM, ADaM) and Computer System Assurance frameworks.
- Experience managing cross-functional teams and SaaS-based vendors
- Excellent communication and problem-solving skills.
Nice To Haves
- Experience with clinical data management (EDC, CDB) and Biometric analytical platforms preferred.
Responsibilities
- Serve as the lead IT partner across Clinical Operations, Data Management, Biometrics.
- Oversee systems supporting regulatory submissions, pharmacovigilance, and quality management.
- Support complex clinical trials involving decentralized models, subject diaries, and connected devices.
- Lead implementation and support of R&D systems including Clinical Trial management solutions including CTMS, EDC, eTMF, ePRO/eCOA, IRT, and consolidated clinical analytics solutions.
- Spearhead use & enablement of AI solutions within R&D, Clinical & Quality systems.
- Develop integration strategy across clinical data ecosystems including the Veeva Vault R&D Suite and analytics environments.
- Ensure compliance with GxP regulations including ICH E6(R3), 21 CFR Part 11, and data integrity (ALCOA+).
- Lead technology solutioning including vendor selection, RFP processes, and vendor relationship management.
- Manage system roadmap, budgeting, and portfolio prioritization.
Benefits
- health insurance coverage
- state tax regulations
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What This Job Offers
Job Type
Full-time
Career Level
Director
