Director, IT R&D And Quality Applications

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.

The Opportunity

Amylyx is looking for a Director, IT R&D and Quality Applications to foster strong functional partnerships and provide strategic technical support.  In this role you will lead the strategy, delivery, and lifecycle management of systems supporting Research, Clinical Development, Data Management, Biometrics, Regulatory, Pharmacovigilance, and Quality functions. Additional responsibilities will include a range of activities within the information technology organization including project management, development, and maintaining procedures to ensure Amylyx has a stable, robust, and scalable set of applications to support the changing business needs and support. This role ensures the operation of scalable, compliant platforms supporting Amylyx's product development pipeline including complex clinical trials and regulatory activities.

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 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.

Required 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.
• 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.
• Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis.
• If outside of the New England region, 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, which may include travel by air, driving or public transportation.
• When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation

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

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Amylyx Pharmaceuticals is an Equal Opportunity Employer 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 conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. 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. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.