Associate Director, External Data Acquisition And Delivery

Regeneron Pharmaceuticals, Inc; Cambourne; Hybrid; GBP 113,000 - 150,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director, External Data Acquisition and Delivery (EDAD) to lead data strategy across clinical trials and ensure high-quality external data delivery from vendors.

You will oversee data platforms, reconciliation processes, and regulatory compliance, partnering with CDM, CROs, and vendors to drive excellence. The role combines strategic leadership with hands-on governance of data flows, DTS development, and performance metrics while mentoring a

Qualifications

• 10+ years in Clinical Data Acquisition/Management in biotech/pharma.
• 4+ years of people management experience.
• Experience overseeing external data reconciliation between EDC and vendor platforms.
• Knowledge of 21 CFR Part 11, ICH-GCP, CDISC standards.

Responsibilities

• Lead External Data Acquisition, integration, quality oversight and delivery strategy.
• Serve as portfolio-level lead for external data quality and operational strategy.
• Review vendor specs and data flows; maintain DTS documents for compliance.
• Mentor on external data services including biomarker, eSource, imaging, ECG, PK, genomics, lab data.
• Oversee vendor relationships, onboarding, qualification, governance and KPIs.

Skills

Leadership

Vendor management

Data reconciliation

Project management

Regulatory compliance

Communication

Strategic thinking

Education

Bachelor's degree in Science

Advanced degree preferred

Tools

Medidata Rave

Veeva

Oracle Inform

SAS

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Clinical Data Management team.

As an Associate Director, External Data Acquisition and Delivery (EDAD), 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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Warren, NJ
• Hybrid; 4 days per week on site
• 25% Travel may be required

Discover your role:

• 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

This role requires:

• Minimum 10+ years of experience in ClinicalData Acquisition/Management withinbiotechnology, 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
• 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