R42183 Associate Director, External Data Acquisition and Delivery

Achievements

None specified.

About the role

You will provide strategic oversight and operational leadership for External Data Acquisition and Delivery activities across Regeneron's clinical trial portfolio and initiatives. You will ensure readiness of external data collection platforms, data conformance tools, reconciliation processes, and the delivery of high-quality, compliant external data from third-party vendors including laboratory, biomarker, Digital Health Technologies, imaging, ECG, PK, genomics, and specialty data. You will 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.

Responsibilities

• Leading External Data Acquisition, integration, quality oversight, and delivery strategy across the clinical trial portfolio
• Serving as a portfolio-level lead for external data quality and clinical-data operational strategy
• Reviewing protocol requirements, vendor specifications, and operational data flows
• Leading all aspects of development and maintenance of Data Transfer Specification (DTS) documents to ensure compliance with Regeneron standards and timelines
• Providing expert mentorship on external data services including biomarker, eSource, eCOA, imaging, ECG, PK, genomics, and laboratory data
• Driving external vendor oversight, onboarding, qualification, governance, and ongoing performance monitoring
• Establishing and handling vendor KPIs, SLAs, and quality metrics
• Governing reconciliation activities between EDC systems and vendor data platforms to ensure data integrity and consistency
• Monitoring reconciliation metrics, discrepancy trends, and resolution timelines across studies
• Collaborating with Database Development, Biostatistics, Study Data Managers, and external vendors to resolve complex data discrepancies
• Leading process improvement initiatives, automation opportunities, and implementation of innovative external data solutions
• Managing and developing a team of EDAD Managers, Specialists, and associates through coaching, mentoring, and performance management
• Supporting SOP development, inspection readiness, audit activities, and regulatory compliance
• Representing EDAD in leadership forums, governance committees, and technology discussions

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
• Ability to work effectively in a fast-paced, matrixed, and global environment

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