Amylyx Pharmaceuticals
Director, IT R&D and Quality Applications
Cambridge, MA · Director
Sponsorship not specified$206k-$232kDetected 5 days ago
Project ManagementBudgetingRecruitingClinical TrialsPharmacovigilanceResearchCommunicationProblem SolvingGxP
About the role
- This role ensures the operation of scalable, compliant platforms supporting Amylyx's product development pipeline including complex clinical trials and regulatory activities.
- We anticipate hiring the Director, IT R&D and Quality Applications in September 2026.
Responsibilities
- Serve as the lead IT partner across Clinical Operations, Data Management, Biometrics.
- 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.
- Develop integration strategy across clinical data ecosystems including the Veeva Vault R&D Suite and analytics environments.
- Lead technology solutioning including vendor selection, RFP processes, and vendor relationship management.
- Manage system roadmap, budgeting, and portfolio prioritization.
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)
- Strong knowledge of GxP regulations, CDISC standards (SDTM, ADaM) and Computer System Assurance frameworks.
- Experience managing cross-functional teams and SaaS-based vendors
Nice to have
- Experience with clinical data management (EDC, CDB) and Biometric analytical platforms preferred.
Compensation
- The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
- Estimated Pay Range
- $206,000 - $232,000 USD
- Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.
Benefits
- The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.
Equal opportunity
- If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
Visa & Work Authorization
- that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related condition
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This listing is sourced directly from Amylyx Pharmaceuticals's careers page and normalized into a canonical job model.