Director, IT R&D & Quality Apps – Remote

Amylyx Pharmaceuticals

Cambridge (MA)

Hybrid

USD 206,000 - 232,000

Full time

14 days+

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Job summary

Amylyx Pharmaceuticals seeks a Director of IT R&D and Quality Applications to lead strategy, delivery, and lifecycle management of systems supporting Research, Clinical Development, Data Management, Biometrics, Regulatory, Pharmacovigilance, and Quality functions.

The role includes project management, development, and procedures to ensure scalable, compliant platforms for clinical trials and regulatory activities. Strong vendor and cross-functional leadership are essential.

Qualifications

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).
Experience with clinical data management (EDC, CDB) and Biometric analytical platforms preferred.
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.

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 CTMS, EDC, eTMF, ePRO/eCOA, IRT, and analytics.
Spearhead use & enablement of AI solutions within R&D, Clinical & Quality systems.
Develop integration strategy across clinical data ecosystems including 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.