Associate Director, Clinical Compliance & Records

The Opportunity

The Associate Director, Clinical Compliance, will partner closely with Clinical Operations leadership and Study Management Teams (SMTs) to ensure Amylyx clinical trials are conducted in compliance with SOPs, ICH/GCP standards, and applicable global regulatory requirements.

Reporting to the Director, Clinical Compliance & Records, this role provides leadership, strategy, and execution of clinical compliance activities and drives inspection readiness. This individual will play a critical role in strengthening sponsor oversight, managing risks, and driving continuous process improvement across clinical programs.

Responsibilities

• Provide strategic guidance to Study Management Teams (SMTs) on ICH-GCP, FDA, and global regulatory requirements, ensuring compliance across the full clinical trial lifecycle
• Lead identification, assessment, and mitigation of compliance risks, including oversight of investigations, Quality Events (QEs), CAPAs, risk assessments, and continuous process improvement initiatives
• Partner cross-functionally to support sponsor oversight activities and development of compliance documentation, ensuring alignment with applicable regulatory requirements, industry standards, and internal procedures
• Drive inspection and audit readiness by coordinating preparation, participation, and follow-up activities, including review of essential regulatory documentation, compliance processes, and remediation activities
• Serve as a clinical compliance subject matter expert, providing guidance on GCP requirements, sponsor responsibilities, inspection preparedness, and risk-based quality management (RBQM)
• Establish and manage SOPs, training frameworks, compliance metrics, and periodic review processes to ensure ongoing compliance, operational consistency, audit readiness, and continuous improvement

Requirements

• Bachelor’s degree in a scientific or health-related discipline
• 8+ years of experience in the pharmaceutical or biotechnology industry, with a focus on Clinical Compliance and Clinical Operations
• Strong knowledge of ICH-GCP guidelines and FDA regulatory requirements across clinical phases
• Experience working with clinical and electronic quality management systems (QMS) such as Veeva Clinical and Veeva Quality
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, SharePoint)
• Strong collaboration and stakeholder management skills
• Excellent organizational, communication, and problem-solving abilities
• Ability to thrive in a fast-paced, evolving biotech environment

Preferred Qualifications

• Experience supporting regulatory inspections (e.g., FDA, EMA, MHRA)
• Experience serving as a training administrator in electronic learning management systems (e.g., Veeva Quality Training, Veeva Study Training)
• Experience supporting study teams with developing, facilitating, and maintaining Risk Assessment Categorization Tools (RACTs), risk registers, and risk logs to identify, assess, monitor, and mitigate clinical trial risks

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, which may include travel by air, driving or public transportation.
• You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location