Amylyx Pharmaceuticals

Senior Director, Clinical Data Management

Cambridge, MA · Director

Sponsorship not specified$12k-$15kDetected 12 days ago

GCPProcess ImprovementRecruitingICD-10Clinical TrialsLeadership

About the role

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.

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
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
Experience building, scaling, or transforming Clinical Data Management organizations
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 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.

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
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

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
Estimated Pay Range
$245,000 - $276,000 USD
Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

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.

If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related condition

This listing is sourced directly from Amylyx Pharmaceuticals's careers page and normalized into a canonical job model.