Director, IT R&D and Quality Applications

Amylyx Pharmaceuticals is seeking a Director, IT R&D and Quality Applications in Cambridge, MA. This full-time opportunity allows you to provide strategic leadership over technology platforms critical to product development.

About the Role

Amylyx Pharmaceuticals anticipates hiring for the Director, IT R&D and Quality Applications role in Cambridge, MA in September 2026. In this full-time capacity you will develop productive functional alliances and deliver strategic technical direction. The job focuses on overseeing the strategy, delivery and lifecycle of applications that support Research, Clinical Development, Data Management, Biometrics, Regulatory, Pharmacovigilance, and Quality. Added duties consist of project management, system development and maintaining procedures that keep applications stable, robust and scalable as business needs evolve. Platforms must operate at scale under full compliance to support the product development pipeline, complex clinical trials and regulatory activities. Estimated pay ranges from $206,000 to $232,000 USD depending on a candidate’s experience, skills, and qualifications as well as internal equity.

What You'll Do

• Establish a position as the main collaborating technology resource for Clinical Operations, Data Management and Biometrics.
• Supervise the systems that sustain regulatory submissions, pharmacovigilance and quality management.
• Assist complex clinical trials featuring decentralized models, subject diaries and connected devices.
• Guide launch and support of R&D systems that include CTMS, EDC, eTMF, ePRO/eCOA, IRT, and consolidated clinical analytics solutions.
• Advance the application and enablement of AI solutions in R&D, Clinical and Quality systems.
• Create an integration strategy covering clinical data ecosystems that include the Veeva Vault R&D Suite and analytics environments.
• Uphold compliance with GxP regulations that include ICH E6, 21 CFR Part 11, and data integrity standards (ALCOA+).
• Steer technological resolutions involving vendor selection, RFP processes, and ongoing vendor relationship management.
• Administer the system roadmap, budgeting activities, and portfolio prioritization.

Skills & Qualifications

• Bachelor’s degree in computer science, life sciences, or a related field.
• At least 10 years in life sciences business applications with 5+ years implementing and supporting R&D and Clinical Systems.
• Mandatory practical experience involving clinical trial systems such as CTMS, eTMF, eCRO, and ePRO.
• Background in clinical data management (EDC, CDB) and Biometric analytical platforms is preferred.
• Profound knowledge of the Veeva Vault R&D Suite covering Clinical, RIM, Quality, and Safety.
• Skill integrating complex clinical data sources that include ePRO, wearables, and medical devices.
• Thorough command of GxP regulations, CDISC standards (SDTM, ADaM) and Computer System Assurance frameworks.
• Proven ability guiding multi-function groups and SaaS suppliers.
• High-level communication capacity and problem-solving aptitude.

About the Company

Amylyx Pharmaceuticals is a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The firm is driven to bring novel therapies to diseases that currently have limited treatment options, approaching each challenge with speed, careful scientific process, and strong commitment to the people affected. Personnel form the foundation, guided by values emphasizing bold initiative, curious exploration, authentic interaction, full engagement, and personal accountability that together nurture a culture of care. A skilled team stands prepared for action given that the communities rely on rapid progress. Professionals who share this focus on addressing medicine’s most difficult problems will find the environment at Amylyx Pharmaceuticals in Cambridge, MA rewarding.

Next Steps

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.