Associate Director, External Data Acquisition and Delivery

BioSpace; New Jersey; Hybrid; USD 155,000 - 253,000; Full time

Job summary

Regeneron seeks an Associate Director, External Data Acquisition and Delivery (EDAD) to lead data strategy and operational excellence across the clinical trial portfolio. You will oversee external data readiness, conformance, and delivery from third-party vendors including biomarker, imaging, ECG, PK, and genomics data.

You will manage a team of EDAD Managers and Specialists, drive process improvements, and ensure compliance with 21 CFR Part 11, ICH-GCP, and CDISC standards in a fast-paced,

Qualifications

• Minimum 10+ years of experience in Clinical Data Acquisition/Management in biotech, pharma, or healthcare.
• Minimum 4+ years of people management experience.
• Experience overseeing external data reconciliation between EDC and vendor platforms.
• Strong knowledge of external data reconciliation processes and ICH-GCP/CDISC standards.

Responsibilities

• Lead External Data Acquisition, integration, quality oversight, and delivery strategy across the clinical trial portfolio.
• Serve as 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 documents to ensure Regeneron standards and timelines.
• Mentor on external data services including biomarker, eSource, eCOA, imaging, ECG, PK, genomics, and laboratory data.
• Oversee vendor onboarding, qualification, governance, and performance monitoring.
• Establish KPIs, SLAs, and quality metrics for vendors.
• Governing reconciliation between EDC and vendor data platforms to ensure data integrity.

Skills

Leadership

Strategic thinking

Project management

Stakeholder management

Communication

Mentoring

People management

Analytical skills

Education

Bachelor's degree in Science

Advanced degree

Tools

Medidata Rave

Veeva

Oracle Inform

SAS

CSV

XML

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 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
• Bachelors 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

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$154,800.00 - $252,800.00