Senior Director, Clinical Data Management

Responsibilities

• Establish and execute the Clinical Data Management strategy aligned with Amylyx’s development and growth objectives
• Build and scale an internal Clinical Data Management organization and the operational roadmap for bringing selected Data Management activities in-house
• Provide leadership and accountability for all Clinical Data Management activities across Amylyx-sponsored clinical trials
• Ensure high-quality data collection, integration, and delivery to support regulatory submissions and business decision-making
• Oversee end-to-end data management deliverables, including study start-up, database design, edit check strategy, reconciliation, database lock, and submission readiness
• Lead the evaluation and implementation of data management technologies, systems, and process improvements
• Develop and manage vendor and CRO relationships, including governance, performance metrics, and quality oversight
• Establish and maintain departmental SOPs, work instructions, governance structures, and operating models
• Ensure compliance with GCP, ICH, and applicable regulatory standards, and lead inspection readiness activities

Requirements

• 12-15 years and BA/BS, 10-12 years and MA/MS, or 5+ years and PhD
• 6+ years of leadership experience managing Clinical Data Management teams and functions
• Demonstrated success supporting Phase 2 and Phase 3 clinical programs
• Experience building, scaling, or transforming Clinical Data Management organizations
• Strong knowledge of EDC systems, clinical data standards, medical coding, and data reconciliation processes
• Experience supporting major regulatory submissions, such as NDA, BLA, or MAA
• Proven ability to influence cross-functional stakeholders and senior leadership

Preferred Qualifications

• Experience transitioning data management activities from outsourced to in-house models
• Familiarity with risk-based methodologies, automation, and advanced data management technologies
• Track record of driving process optimization and operational excellence initiatives

About the Company

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