Senior Director, Clinical Data Management
External
Amylyx · Cambridge, MAPrepare for this interview
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About the role
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
- 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.
Benefits
Additional Information
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.
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