Associate Director, External Data Acquisition and Delivery

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health and wellness plans

401(k) company match

Annual bonuses

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking an Associate Director for External Data Services to oversee a talented team dedicated to ensuring compliance and efficiency in data management processes. This role demands expert knowledge in regulatory practices and strong leadership skills while mentoring team members.

The ideal candidate will have over 10 years of experience in External Clinical Data Management and at least 4 years of people-management experience.

Join us to drive innovative strategies and enhance external data processes within our dynamic work environment.

Qualifications

• Minimum of 10+ years of experience in External Clinical Data Management.
• At least 4 years of people-management experience.
• Hands-on experience with Imaging Data is required.

Responsibilities

• Shape and implement the strategy for External Data Services.
• Oversee development and maintenance of DTS documents.
• Lead and manage a team of External Data Services Managers.

Skills

Leadership

Data Management

Regulatory Knowledge

Problem Solving

Interpersonal Communication

Education

Bachelor’s degree in Science, Health, Computing, or related field

Tools

SAS

CSV

XML

Job description

The Associate Director, External Data Services, plays a critical leadership role, overseeing team members to ensure all activities align with Regeneron’s procedures and industry best practices. This position collaborates closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs. The role involves coaching, mentoring, and managing the performance of direct reports while contributing to the department’s strategic direction and working with senior leadership to define goals, staffing needs, and departmental structure.

A Typical Day

• Shape and implement the strategy for External Data Services.
• Lead and manage a team of External Data Services Managers and Specialists.
• Oversee the development and maintenance of all DTS documents, ensuring alignment with Regeneron standards and timelines.
• Drive the External Data Vendor Oversight model, establishing effective communication, partnership-level processes, and portfolio-level transparency on DTS status and escalations.
• Represent External Data Services in leadership forums and technology discussions.
• Contribute to and execute the External Data Services technology strategy.
• Provide expert-level guidance to CROs, stakeholders, and external vendors on External Data Services.
• 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 a subject matter expert (SME) for complex topics requiring leadership-level 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.

This Role Might Be for You If You

• Have expert knowledge of regulations such as 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.
• Possess deep expertise in Data Management, External Data processes, and industry best practices.
• Demonstrate advanced experience with extracting data in SAS, CSV, and XML formats.
• Can address complex External Data challenges and recommend actionable solutions.
• Have a proven ability to develop best practices and processes to achieve objectives.
• Exhibit strong problem‑solving, analytical, and project management skills.
• Thrive in a matrix environment with virtual teams and can motivate others effectively.
• Possess an excellent understanding of cross‑functional activities and their intersections with External Data.
• Manage multiple priorities with attention to detail and deliver results within tight timelines.
• Communicate effectively through strong interpersonal, oral, and written skills.
• Adapt quickly in a fast‑paced, dynamic environment.
• Be open to travel up to 20%.

Required Qualifications

• Minimum of 10+ years of experience in External Clinical Data Management, with expert knowledge of database structures in biotechnology, pharmaceutical, or health‑related industries.
• At least 4 years of people‑management experience.
• Bachelor’s degree in Science, Health, Computing, or a related field.
• Hands‑on experience with Imaging Data is required.
• Advanced knowledge of Biomarker data types and/or Imaging Data for oncology and non‑oncology studies is a plus.
• Expert knowledge of database structures is preferred.

Benefits

Regeneron offers a comprehensive benefits program that may include health and wellness plans, fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. Additional information about Regeneron benefits in the U.S. can be found on https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Equal Opportunity Employer

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the company’s business.