Associate Director, External Clinical Data Management

The Associate Director of External Data Services will lead a team to align all activities with Regeneron procedures and industry best practices. The role collaborates with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with SOPs, coaches managers, and defines departmental strategy.

• Shape and implement the strategy for External Data Services.
• Lead and manage a team of External Data Services Managers and Specialists.
• Oversee development and maintenance of all DTS documents, ensuring alignment with company standards, processes, and timelines.
• Drive the External Data Vendor Oversight model, establishing effective communication and portfolio-level transparency on DTS status and escalations.
• Represent External Data Services in leadership forums and technology discussions.
• Contribute to and execute the technology strategy for External Data Services.
• Provide expert-level guidance to CROs, stakeholders, and external vendors.
• Identify process gaps and lead initiatives to improve processes.
• Track milestones and deliverables, escalating issues and communicating portfolio-level updates to stakeholders.
• Lead or contribute to special projects requiring strategic input and expertise in External Data.
• Serve as subject‑matter expert for complex topics requiring leadership commitment.
• Develop SOPs, work instructions, guidance manuals, and other DTS development tools.
• Provide coaching, mentoring, and performance management for direct reports.
• Manage resource allocation and planning for External Data Services.

• Minimum 10 years’ experience in External Clinical Data Management in biotechnology, pharmaceutical, or health‑related industries.
• Expert knowledge of 21 CFR Part 11, ICH GCP, CDISC, and related data‑collection regulations.
• Deep expertise in Data Management and External Data processes, inclusive of extracting data in SAS, CSV and XML formats.
• Hands‑on experience with Imaging Data and, preferably, biomarker data types for oncology and non‑oncology studies.
• Strong problem‑solving, analytical and project‑management skills.
• Excellent communication skills and experience working in a matrix, virtual team environment.
• Ability to manage multiple priorities and deliver results within tight timelines.
• Travel up to 20%.
• Minimum 4years of people‑management experience.
• Bachelor’s degree in Science, Health, Computing or related field.

• Experience developing best‑practice procedures and processes.
• Advanced knowledge of database structures in biopharma settings.

Salary range: $ – $ annually. The position is located in the U.S.; relocation may be available. Benefits include health, dental, vision, life and disability insurance, 401(k) with company match, paid time off, and other applicable benefits. For details, visit the Regeneron careers site.

Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, domestic partnership status, age, citizenship, or any other protected characteristic. The Company will provide reasonable accommodation for qualified applicants with disabilities or chronic illnesses unless undue hardship would result.