At a Glance
- Tasks: Lead IT strategy and support for innovative clinical research and quality applications.
- Company: Join Amylyx, a pioneering company transforming treatment for high unmet medical needs.
- Benefits: Competitive salary, remote work options, and a culture of caring and collaboration.
- Other info: Remote work available, with opportunities for travel and professional growth.
- Why this job: Make a real impact in healthcare by tackling some of medicine's toughest challenges.
- Qualifications: 10+ years in life sciences IT with expertise in clinical systems and data management.
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.
We anticipate hiring the Director, IT R&D and Quality Applications in September 2026.
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.
Director, IT R&D and Quality Applications in Cambridge employer: Amylyx Pharmaceuticals
At Amylyx, we are driven by our mission to transform the treatment landscape for diseases with high unmet needs, fostering a culture of audacity, curiosity, and accountability. Our commitment to employee growth is reflected in our supportive work environment, where innovative ideas are encouraged, and remote work opportunities allow for flexibility. Join us in Cambridge, MA, where you will be part of a dedicated team making a real impact in the lives of patients while enjoying competitive compensation and comprehensive benefits.
StudySmarter Expert Advice🤫
We think this is how you could land Director, IT R&D and Quality Applications in Cambridge
✨Join the IT Consultancy Buzz
Get involved in local or virtual IT consultancy meetups and forums. This is where we can rub shoulders with industry professionals, get insights into what Amylyx Pharmaceuticals values, and even spot unadvertised opportunities. Don't miss out on these chances to make a name for ourselves in the IT world!
✨Show Off Your Skills
Create a personal project or case study relevant to the challenges Amylyx Pharmaceuticals might face. Use platforms like GitHub or Medium to share your findings. This not only demonstrates our consulting skills but shows a proactive attitude, making us stand out from the crowd when applying for that full-time gig.
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Follow and engage with the relevant thought leaders and influencers in IT consultancy on LinkedIn. Share insightful content and join discussions to gain visibility. A well-placed comment or shared article could catch the attention of someone at Amylyx Pharmaceuticals!
✨Direct Apply to Amylyx Pharmaceuticals
Let's not forget to apply directly through the Amylyx Pharmaceuticals website! Tailor your application to showcase our understanding of their consulting style and how we can contribute to their projects. A personalised approach can make a huge difference in landing that full-time position!
We think you need these skills to ace Director, IT R&D and Quality Applications in Cambridge
Some tips for your application 🫡
Showcase Your Problem-Solving Skills:In IT consulting, it's all about problem-solving, so make sure your CV highlights your analytical skills and any relevant projects you've tackled. Mention specific technologies or methodologies you've used to resolve issues or improve processes; this shows you can think critically and deliver results, which is vital for us at Amylyx Pharmaceuticals.
Highlight Relevant Certifications:Certifications like ITIL, PMP, or even specific tech stack qualifications can really make you stand out. Make sure to include these in your CV, as they not only demonstrate your expertise but also your commitment to staying current in the field. We love seeing candidates who are proactive about their professional development!
Tailor Your Cover Letter:Your cover letter is your chance to connect personally with us at Amylyx Pharmaceuticals. Share stories about your experiences in IT consulting, and how they shaped your desire to join our team. Mention why you’re excited about this particular role, and how you see yourself contributing to our projects.
Keep It Clear and Concise:We're all busy, so make sure your application is easy to read. Use bullet points for key achievements, and don’t overload us with jargon. A clean, professional layout goes a long way. Remember, the clearer your application, the more likely we are to invite you in for an interview!
How to prepare for a job interview at Amylyx Pharmaceuticals
✨Brush Up on Your Technical Skills
For an IT consulting role, be ready to demonstrate your technical prowess. You might face questions on systems integration, cloud technologies, or even troubleshooting specific software. If you have experience with tools like AWS, Azure, or even specific programming languages, make sure you can talk about them fluently.
✨Showcase Your Problem-Solving Approach
IT consulting is all about solving problems for clients. Think about how you can illustrate your approach to a past challenge using the STAR method (Situation, Task, Action, Result). It's a great way to show how you tackle complex issues and come up with effective solutions.
✨Know the Business Impact of IT Solutions
When discussing your experiences, focus not just on the tech solutions you implemented, but also on their business impact. Employers want to see that you can connect IT with organisational goals. Prep examples that highlight how your tech contributions improved efficiency or reduced costs for past clients or projects.
✨Prepare for Behavioural Questions
Since IT consulting often involves teamwork and client interactions, expect behavioural questions that assess your interpersonal skills. Be prepared with examples that demonstrate your adaptability, communication skills, and how you handle client feedback. Before the interview, think of situations where you worked closely with clients to create effective IT strategies or changes.
