Vice President, Clinical Compliance and Systems Cambridge, MA

Cambridge, MA

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 seeking an experienced and strategic Vice President, Clinical Compliance & Systems to join our Clinical Operations leadership team. This newly created role will provide leadership and vision for two increasingly important capabilities within Clinical Operations:
Clinical Compliance and Clinical Systems . In this role, “systems” refers to the operating model of Clinical Operations — the processes, governance, standards, tools, data practices, workflows, and oversight mechanisms, including the business use of clinical platforms, that support compliant, efficient, and scalable clinical trial execution.

As Amylyx continues to advance and expand its clinical development portfolio, we are evolving our Clinical Operations model to build greater internal capability, strengthen oversight of clinical trial execution, and implement scalable processes and systems that enable high-quality, compliant, and data-driven decision making.

The Vice President, Clinical Compliance & Systems will be responsible for establishing and advancing the strategy, infrastructure, processes, and capabilities required to support this evolution. The individual will oversee clinical compliance, inspection readiness, Trial Master File (TMF) strategy and governance, and the development and implementation of clinical systems and technologies supporting Clinical Operations.

This leader will partner closely across Clinical Operations, Development Sciences, Quality, IT, and other functions to ensure Amylyx’s clinical operating infrastructure evolves with the needs of its programs and pipeline. This is an opportunity for a highly collaborative leader to build and shape a growing function , balancing strong compliance and operational discipline with innovation, agility, and fit-for-purpose solutions.

Responsibilities

• Provide strategic leadership and vision for the Clinical Compliance and Clinical Systems functions within Clinical Operations, establishing scalable capabilities to support Amylyx’s clinical portfolio.
• Build, lead, develop, and mentor a high-performing team responsible for clinical compliance, TMF oversight, clinical systems, and related capabilities.
• Establish the long-term strategy and roadmap for Clinical Compliance and Clinical Systems, ensuring investments are appropriately sequenced and aligned with Clinical Operations and broader Development priorities.
• Provide leadership for clinical compliance activities supporting the execution of Amylyx-sponsored clinical trials in accordance with applicable regulations, ICH-GCP requirements, internal standards, and industry best practices.
• Establish and maintain a robust framework for inspection readiness , partnering across functions to ensure ongoing preparedness for regulatory inspections and audits.
• Provide strategic oversight and governance of Amylyx’s electronic Trial Master File…