Senior Director, Clinical Data Management

Role Overview

• Build and lead a strong regional Clinical Data Management organization to expand internal capabilities across clinical data reporting, data review, coding, laboratory data processing, database build and testing, and external data delivery.
• Define and supervise functional metrics, KPIs, and KQIs to supervise quality, compliance, and timely delivery.
• Be responsible for the delivery of high-quality laboratory data, coded terminology, and external data to support statistical analysis across the portfolio.
• Provide effective oversight of FSPs and external data vendors.
• Identify operational risks early and implement practical solutions to support critical study turning points globally.
• Evaluate resource needs and allocation to maintain strong productivity and delivery against functional goals.
• Shape organization design, hire top talent, and support performance and development across the team.
• Lead cross-functional initiatives that improve efficiency, strengthen operations, and support inspection readiness.
• Advance the use of automation and AI/GenAI solutions to reduce manual effort, improve data quality, and enable faster data access.
• Build strong partnerships across internal teams and external collaborators to support collaboration throughout the drug development process.
• Chip in to the development of global SOPs, WIs, BPTs, and training curricula for Clinical Data Management.
• Model company values through collaboration, innovation, accountability, respect, and sound leadership.
• Stay current on emerging trends, technologies, and standard methodologies in Clinical Data Management, and represent Regeneron in industry forums and professional associations.

Requirements

• Leadership experience in Clinical Data Management or a related field, including leading medium to large teams (50–150) supporting global data management functions.
• Strong expertise in clinical data management processes, industry procedures, and key clinical systems such as EDC, eSource, eCOA, IRT, Clinical Data Repositories, medical coding platforms, and laboratory normal range repositories.
• Experience assessing cases, running proof-of-concept initiatives, and scaling effective technical solutions to address operational challenges.
• Sophisticated knowledge of clinical data management principles, technologies, regulations, and standards, including 21 CFR Part 11, ICH-GCP, GxP, and GDPR.
• Strong discernment and a broad understanding of the pharmaceutical or biotech industry.
• A track record of solving complex business problems, leading transformation, and navigating change such as new operating models, acquisitions, or portfolio shifts.
• The ability to influence and build trusted relationships with senior collaborators across functions and levels.
• Success in building high-performing teams focused on innovation, transformation, and operational excellence.
• Strong communication and collaborator leadership skills.
• The ability to operate efficiently in a fast-paced environment.
• Willingness to travel up to 25%.

Tech Stack

• Google Cloud Platform

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave) for eligible employees at all levels