Note: The job is a remote job and is open to candidates in USA. Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs. They are seeking a strategic and experienced Senior Director, Clinical Data Management to lead the evolution of their Clinical Data Management function and ensure the delivery of high-quality data to support regulatory submissions and business decisions.
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
Skills
- 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
- 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
Benefits
- At Amylyx, we proudly support remote work opportunities within the United States.
- 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.
- You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
- Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
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