Senior Director, External Data Acquisition & Delivery

Role Summary

The Senior Director, External Data Acquisition & Delivery is a member of Regeneron’s Data Management Senior Leadership Team (DMSLT) and leads the end-to-end delivery of external data sources (central labs, specialty labs, biomarkers, companion diagnostics, eCOA, IRT, and others) to support Regeneron’s clinical pipeline globally. This role oversees data collection, acquisition, transfer, processing, quality management and reconciliation, and drives digital transformation strategies and automation related to external data, protocols, eSource, and EHR/EMR-to-EDC integrations to streamline external data acquisition, improve data quality and accelerate clinical insights. The position collaborates with Data Management Portfolio Delivery, Data Management Central Services, Clinical Data Operations and internal/external stakeholders to ensure continuous improvement and successful study outcomes.

Responsibilities

• Establish and implement the global strategy and delivery roadmap for external data acquisition and delivery to enhance internal capabilities in data collection and standardization, external data acquisition via APIs and external data/systems integrations, automated data quality control and reconciliation, and data reporting using innovative platforms and technologies.
• Accountable for the end-to-end delivery of fit-for-purpose participant data from a variety of external data sources (central labs, specialty labs, biomarkers, companion diagnostics, digital health wearables, eCOA, IRT, etc.).
• Define robust functional metrics and KPIs/KQIs to monitor external partners’ quality, SOP compliance and timely delivery.
• Champion automation and AI/GenAI-enabled solutions to reduce manual data handling and processing and enable faster data accessibility, increase data quality and workflow efficiencies.
• Liaise with internal and external stakeholders to foster strong relationships and ensure effective cross-functional collaboration and communication throughout the drug development process.
• Provide vendor and external partner oversight to ensure systems, processes and procedures used during participant-level data acquisition, transmission and storage conform with Regeneron standards and are compliant with 21 CFR Part 11, GxP-, GDPR- and study requirements.
• Lead strategic cross-functional initiatives to promote increased process efficiency and operational excellence; drive optimization of technology, systems and processes focusing on decreased cycle times, improved quality and inspection readiness.
• Proactively identify and propose solutions to mitigate risks for the function globally, ensuring support for critical study data management milestones.
• Evaluate resource demand and allocation to ensure adequate staffing and high levels of productivity in support of departmental objectives and corporate level portfolio delivery goals; define new roles, select and recruit industry top talent and provide constructive performance appraisals to ensure professional growth and development.
• Author and contribute to the development of global clinical data management system SOPs, WIs and BPTs and departmental training curricula.
• Maintain awareness of Data Management emerging trends, technology solutions and industry best practices through peer relationships with thought leaders in the industry; represent Regeneron with professional associations and at industry forums.

Qualifications

• Required: A Bachelor's degree; advanced degree preferred.
• Required: 15+ years of clinical data management experience in a pharmaceutical or biotech setting.
• Required: 10+ years of functional leadership.
• Required: 8+ years people management, leadership and mentoring experience.
• Preferred: Leadership experience in External Data Operations or related field, leading small to medium functional groups supporting global data management line function.
• Preferred: Expertise in clinical data technologies (cloud ecosystems, systems architecture, data integrations, business intelligence solutions) and clinical data systems (EDC, eSource, eCOA, IRT, Clinical Data Repository/data lakes).
• Preferred: Ability to identify and evaluate business cases through proof-of-concept (POC) initiatives and deploy transforming concepts into scalable technical solutions to address operational challenges, increase efficiency and enhance business capabilities.
• Preferred: Advanced knowledge of clinical data management principles, technologies, regulations and best practices, including 21 CFR Part 11, ICH-GCP Guidelines, GxP compliance and GDPR, related to data acquisition, processing, handling and reporting used in drug development.
• Preferred: Deep domain expertise in set up and scale up of cloud platforms, data lakes, data science technologies for automation, data normalization for optimal data organization, accessibility, inter, performance, and data-driven decision making.
• Preferred: Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
• Preferred: Demonstrated success in solving complex business problems, strategic thinking, organizational design, leading through periods of significant change, i.e., operating model shifts, company and/or asset acquisitions.
• Preferred: Ability to build relationships with key internal and external stakeholders at leadership levels and across levels by negotiating effectively, managing conflicts and collaborating successfully.
• Preferred: Proven ability to lead global teams with a focus on transformation, innovation and operational excellence.
• Preferred: Excellent interpersonal, oral, and written communication skills.
• Preferred: Ability to adjust in a fast-paced environment.

Additional Requirements

• May require up to 25% travel.