Senior Director, Clinical Data Management
Amylyx Pharmaceuticals
June 25, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities
- Establish and execute the Clinical Data Management strategy aligned with development and growth objectives.
- Build and scale an internal Clinical Data Management organization and roadmap to bring selected activities in-house while overseeing CRO partnerships.
- Provide leadership and accountability for Clinical Data Management across all Amylyx-sponsored clinical trials.
- Ensure high-quality data collection, integration, and delivery to support regulatory submissions and business decisions.
- Oversee end-to-end data management deliverables (study start-up, database design, edit checks, reconciliation, database lock, submission readiness).
- Lead evaluation and implementation of data management technologies, systems, and process improvements.
- Develop and manage vendor/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; lead inspection readiness.
Required Qualifications
- 12–15 years with BA/BS, 10–12 years with MA/MS, or 5+ years with PhD.
- 6+ years leading Clinical Data Management teams/functions.
- Demonstrated success supporting Phase 2 and Phase 3 programs.
- Experience building/scaling/transforming Clinical Data Management organizations.
- Strong knowledge of EDC systems, clinical data standards, medical coding, and reconciliation.
- Experience supporting major regulatory submissions (NDA, BLA, MAA).
- Proven ability to influence cross-functional stakeholders and senior leadership.
Preferred Qualifications
- Experience transitioning data management from outsourced to in-house models.
- Familiarity with risk-based methodologies, automation, and advanced data management technologies.
- Track record driving process optimization and operational excellence.
Work Location and Conditions
- Remote within the United States; must attend meetings at the Cambridge, MA office regularly. Preference for New England residents.
- Remote work requires privacy, reliable internet, phone access, and ability to video conference.
Compensation
- Estimated pay range: $245,000–$276,000 USD.
- Establish and execute the Clinical Data Management strategy aligned with development and growth objectives.
- Build and scale an internal Clinical Data Management organization and roadmap to bring selected activities in-house while overseeing CRO partnerships.
- Provide leadership and accountability for Clinical Data Management across all Amylyx-sponsored clinical trials.
- Ensure high-quality data collection, integration, and delivery to support regulatory submissions and business decisions.
- Oversee end-to-end data management deliverables (study start-up, database design, edit checks, reconciliation, database lock, submission readiness).
- Lead evaluation and implementation of data management technologies, systems, and process improvements.
- Develop and manage vendor/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; lead inspection readiness.
Required Qualifications
- 12–15 years with BA/BS, 10–12 years with MA/MS, or 5+ years with PhD.
- 6+ years leading Clinical Data Management teams/functions.
- Demonstrated success supporting Phase 2 and Phase 3 programs.
- Experience building/scaling/transforming Clinical Data Management organizations.
- Strong knowledge of EDC systems, clinical data standards, medical coding, and reconciliation.
- Experience supporting major regulatory submissions (NDA, BLA, MAA).
- Proven ability to influence cross-functional stakeholders and senior leadership.
Preferred Qualifications
- Experience transitioning data management from outsourced to in-house models.
- Familiarity with risk-based methodologies, automation, and advanced data management technologies.
- Track record driving process optimization and operational excellence.
Work Location and Conditions
- Remote within the United States; must attend meetings at the Cambridge, MA office regularly. Preference for New England residents.
- Remote work requires privacy, reliable internet, phone access, and ability to video conference.
Compensation
- Estimated pay range: $245,000–$276,000 USD.