Associate Director, External Clinical Data Management

Role Summary

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 also involves coaching, mentoring, and managing the performance of direct reports, while contributing to the department's strategic direction. Additionally, the AD works with senior leadership to define goals, staffing needs, and departmental structure.

Responsibilities

• 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, processes, 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, escalate issues, and communicate 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.

Qualifications

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

Skills

• Expert knowledge of regulations like 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.
• Deep expertise in Data Management, External Data processes, and industry best practices.
• Advanced experience with extracting data in SAS, CSV, and XML formats.
• Ability to address complex External Data challenges and recommend actionable solutions.
• Ability to develop best practices and processes to achieve objectives.
• Strong problem-solving, analytical, and project management skills.
• Ability to thrive in a matrix environment with virtual teams and motivate others effectively.
• Excellent understanding of cross-functional activities and their intersections with External Data.
• Strong multitasking and attention to detail with the ability to deliver results within tight timelines.
• Excellent interpersonal, oral, and written communication skills.
• Adaptability in a fast-paced, dynamic environment.

Education

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

Additional Requirements

• Travel up to 20%.