> Markdown version of [/jobs/ext/1330133-director-it-r-d-and-quality-applications](https://www.wearedevelopers.com/jobs/ext/1330133-director-it-r-d-and-quality-applications). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Director, IT R&D and Quality Applications - **Company:** Amylyx Pharmaceuticals - **Location:** Cambridge, MA, United States (Remote available) - **Experience:** Expert - **Salary:** $206,000.0 - $232,000.0 - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, Business Analytics Applications, Biometrics, Business Software, Clinical Data Management, Clinical Data Repository, Clinical Trial Management Systems, Software as a Service, Data Integrity, Enterprise Document Management System, Information Technology, Data Management, Wearables, VeevaVault, GXP - **Published:** July 18, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=a50c8368c53e5045 ## About the Role * 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. ## Description * 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. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Biometric Phone Chargers, $40m Domain Names & AI Movies Winning Awards - Peter Kröner](https://www.wearedevelopers.com/videos/1810-biometric-phone-chargers-40m-domain-names-ai-movies-winning-awards-peter-kroner) - [Coffee with Developers - Maria Apazoglou](https://www.wearedevelopers.com/videos/1209-coffee-with-developers-maria-apazoglou) - [Android beyond mobile: Cars, TVs, and Wearables](https://www.wearedevelopers.com/videos/553-android-beyond-mobile-cars-tvs-and-wearables) - [Reality and Beyond: Coding a Drone Using {Unity 3D .NET} and ChatGPT AI!](https://www.wearedevelopers.com/videos/702-reality-and-beyond-coding-a-drone-using-unity-3d-net-and-chatgpt-ai) - [WeAreDevelopers LIVE - What Development and Tattoos Have in Common and more](https://www.wearedevelopers.com/videos/1380-wearedevelopers-live-what-development-and-tattoos-have-in-common-and-more) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [Best Paying Remote Jobs](https://www.wearedevelopers.com/magazine/255-best-paying-remote-jobs) - [Coffee with Developers - Maria Apazoglou - Making AI understandable for all in production](https://www.wearedevelopers.com/magazine/475-coffee-with-developers-maria-apazoglou-making-ai-understandable-for-all-in-production) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [The Best Job Search Websites of 2025](https://www.wearedevelopers.com/magazine/368-the-best-job-search-websites-of-2025)