Senior Director, Clinical Data Management

The Opportunity

Amylyx Pharmaceuticals is seeking a strategic and experienced Senior Director, Clinical Data Management to lead the evolution of our Clinical Data Management function during a critical stage of company growth. This role will define and execute the long-term vision for data management across the clinical development portfolio, ensuring the delivery of high-quality data to support regulatory submissions and key business decisions.

The Senior Director will build and scale internal capabilities while transitioning from a predominantly outsourced model, establishing the systems, processes, and organizational infrastructure necessary to support late-stage development programs and future commercial operations. This individual will serve as a key leader within the Biometrics organization and collaborate closely with cross-functional stakeholders to drive operational excellence and innovation in 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 while maintaining effective oversight of CRO partnerships
• 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

Required Qualifications

• 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 Requirements

• 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

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations, candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis. Preference will be given to candidates who reside in the New England region and can be in person on an as-needed basis.
• When working remotely, you must have access to a work setting that enables you to meet all requirements of the role, including privacy, reliable internet access, phone access, and the ability to video conference.