Associate Director, Clinical Compliance & Records

The role

The Associate Director, Clinical Compliance will provide leadership, strategy, and execution of clinical compliance activities. This person will partner with Clinical Operations leadership and Study Management Teams to ensure clinical trials comply with SOPs, ICH/GCP standards, and global regulatory requirements.

What you will do

• Provide strategic guidance to Study Management Teams on ICH-GCP, FDA, and global regulatory requirements
• Lead identification, assessment, and mitigation of compliance risks
• Partner cross-functionally to support sponsor oversight activities and development of compliance documentation
• Drive inspection and audit readiness by coordinating preparation, participation, and follow-up activities
• Serve as a clinical compliance subject matter expert
• Establish and manage SOPs, training frameworks, compliance metrics, and periodic review processes

Required qualifications

• 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

Nice to have

• 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

Benefits

• Competitive base pay
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside and/or work in Alaska, Arizona, Hawaii, Michigan and Tennessee
• Must have access to work in setting that meets all requirements of the role including privacy, reliable internet access, phone, and ability to communicate via video conference

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to usher in a new era for treating diseases with high unmet needs.