Director, External Data Acquisition and Delivery

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Hybrid; USD 183,000 - 305,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension

401(k) company match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. in Warren, NJ seeks a Director, External Data Acquisition and Delivery to lead vendor oversight, external data integration, and data transfer specifications across therapeutic areas.

You will shape governance for data quality, integrity and risk, and mature data management models for clinical data across regions. You will collaborate with Digital & Tech, Data Technology and Innovation, and cross-functional partners while mentoring a global team.

Qualifications

• Bachelor's degree in science, health, computing or a related field.
• 12+ years of progressive clinical data management and external data operations.
• Experience leading external data vendor oversight in regulated environments.
• Knowledge of ICH-GCP, 21 CFR Part 11, and CDISC standards.

Responsibilities

• Set the strategic direction for external data acquisition, integration and reconciliation.
• Own governance of data quality, integrity and risk across programs.
• Oversee data management models, onboarding, readiness, and performance monitoring.
• Define Data Transfer Specifications and review plans with cross-functional partners.
• Set reconciliation standards to ensure inspection readiness and compliance.

Skills

Leadership

Vendor oversight

Data management

Cross-functional collaboration

Regulatory compliance

Communication

Education

Bachelor's degree

Tools

Medidata Rave

Veeva

Oracle InForm

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 a Director, External Data Acquisition and Delivery to join our Clinical Data Management. This role provides senior leadership for vendor and provider oversight for data and tech, external data reconciliation, data transfer specifications, external data acquisition capabilities, external data integrity, and inspection readiness across all data types. In this role, you will shape how laboratory, biomarker, eCOA, imaging, genomics, and digital health data are acquired, reconciled, and delivered with quality and speed. You will collaborate with vendors, technology teams, Quality, Procurement, and cross-functional partners while developing a high-performing across multiple regions. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Warren, NJ
• Work model/flexibility: Primarily onsite with hybrid flexibility
• Travel percentage: Up to 20%

Discover your role:

• Set the strategic direction for external data acquisition, integration, and reconciliation across all therapeutic areas
• Own portfolio-level governance of external data quality, data integrity, and risk
• Own and mature the model for data management, including qualification, onboarding, operational readiness, ongoing performance monitoring, and governance for clinical data management domain in collaboration with the cross-functional team.
• Guide Data Transfer Specifications, external data management plans, and review plans with cross-functional partners
• Set EDC-to-vendor reconciliation standards that keep our processes inspection-ready and compliant with ICH-GCP and 21 CFR Part 11
• Advance new data capabilities, digital health technologies, and automation with Digital & Tech and Data Technology and Innovation
• Lead, coach, and develop a global team of Associate Directors, managers, specialists, and associates
• Represent Regeneron in industry forums such as CDISC and SCDM, and deputize for the Global Head as needed

This role requires:

• Bachelor's degree (advanced degree preferred) in Science, Health, Mathematics, Computing, Information Systems, Data Management, or a related field with 12+ years of progressive experience in clinical data acquisition/management, external data operations.
• 5+ years of people leadership, including managing managers or senior professionals
• Experience leading external data vendor oversight, data transfer specification governance, and external data reconciliation in a regulated environment
• Advanced knowledge of ICH-GCP, 21 CFR Part 11, CDISC standards, and EDC platforms such as Medidata Rave, Veeva, or Oracle InForm
• Society of Clinical Data Management or ACRP-CP certification is recommended

Salary Range (annually) $183,100.00 - $305,200.00

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
• 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.

We are committed to building a workplace with an inclusive culture.

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.

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

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 on‑site.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.