Director, IT R&D and Quality Applications

• 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.

• 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.
• Experience managing cross-functional teams and SaaS-based vendors
• Excellent communication and problem-solving skills.

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

5.05.0 out of 5 stars Cambridge, MA $206,000 - $232,000 a year, The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range

$206,000 - $232,000 USD

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.