Associate Director, External Data Acquisition and Delivery

About the role

Provide strategic oversight and operational leadership for External Data Acquisition and Delivery activities across Regeneron’s clinical trial portfolio and initiatives.

Responsibilities

• Lead External Data Acquisition, integration, quality oversight, and delivery strategy across the clinical trial portfolio
• Serve as a portfolio-level lead for external data quality and clinical-data operational strategy
• Review protocol requirements, vendor specifications, and operational data flows
• Develop and maintain Data Transfer Specification (DTS) documents to ensure compliance with Regeneron standards and timelines
• Partner closely with Clinical Data Management, CROs, external vendors, and cross-functional partners to drive external data strategy, operational excellence, vendor oversight, digital transformation initiatives, and process improvements

Requirements

• Strong expertise managing multiple clinical external data types including biomarker, imaging, eCOA, ECG, PK, genomics, laboratory, and Digital Health Technology data
• Advanced knowledge of external data reconciliation processes and EDC platforms such as Medidata Rave, Veeva, or Oracle Inform
• Experience working with SAS, CSV, and XML data formats
• Strong understanding of industry regulations including 21 CFR Part 11, ICH-GCP, and CDISC standards
• Proven experience handling external vendor relationships and driving accountability for quality deliverables
• Strong leadership, people management, coaching, and mentoring capabilities
• Strategic thinking, creativity, problem-solving, and analytical skills
• Strong project management and stakeholder management capabilities
• Excellent verbal and written communication skills

Qualifications

• Minimum 10+ years of experience in Clinical Data Acquisition/Management within biotechnology, pharmaceutical, or healthcare industries
• Minimum 4+ years of people management experience
• Demonstrated experience overseeing external data reconciliation activities between EDC systems and vendor platforms
• Experience driving process improvements and vendor oversight in supervised environments
• Bachelor’s degree in Science, Health, Mathematics, Computing, Information Systems, or a related field
• Advanced degree preferred

Skills

• Expertise managing multiple clinical external data types including biomarker, imaging, eCOA, ECG, PK, genomics, laboratory, and Digital Health Technology data
• Advanced knowledge of external data reconciliation processes and EDC platforms such as Medidata Rave, Veeva, or Oracle Inform
• Experience working with SAS, CSV, and XML data formats
• Strong understanding of industry regulations including 21 CFR Part 11, ICH-GCP, and CDISC standards
• Proven experience handling external vendor relationships and driving accountability for quality deliverables
• Strong leadership, people management, coaching, and mentoring capabilities
• Strategic thinking, creativity, problem-solving, and analytical skills
• Strong project management and stakeholder management capabilities
• Excellent verbal and written communication skills

Benefits

Does not specify

Pay

$154,800.00 - $252,800.00 annually

Schedule

Does not specify