Associate Director, External Clinical Data Management

Role Summary

Associate Director, External Clinical Data Management. The Associate Director, External Data Services leads a team to ensure activities align with procedures and industry best practices, collaborating with Clinical Data Management teams and External Data Vendors to deliver compliant external data. Responsible for coaching, mentoring, performance management, and contributing to the department's strategic direction, while partnering with senior leadership on goals and staffing.

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

• Have expert knowledge of regulations like 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.
• Are open to travel up to 20%.

Education

• Bachelor‚Äôs degree in Science, Health, Computing, or a related field.

Additional Requirements

• 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.
• Minimum 10+ years in External Clinical Data Management; at least 4 years of people management experience.