Senior Director, External Data Acquisition & Delivery

Regeneron Pharmaceuticals • Village of Tarrytown, NY

2d

About The Position

The Senior Director, External Data Acquisition & Delivery is a member of the Data Management Senior Leadership Team (DMSLT) and contributes to the operational vision, direction and strategy of the line function in support of the advancement of Regeneron’s clinical pipeline globally. The incumbent will be accountable for the end-to-end delivery of a variety of external data sources (central labs, specialty labs, biomarker, companion diagnostics, eCOA, IRT, etc.), including, but not limited to, external data collection, acquisition, transfer, processing, quality management and reconciliation. Additionally, this role is responsible for the development and implementation of innovative strategies for digital transformation/digital health technologies and automation as related to external data, protocols, eSource and EHR/EMR-to-EDC integrations that streamline external data acquisition, facilitate timely data availability and improve quality to accelerate clinical data insights and decision making. The Senior Director, External Data Acquisition & Delivery will collaborate closely with the Data Management Portfolio Delivery, Data Management Central Services and Clinical Data Operations teams along with internal stakeholders and external vendors to ensure continuous improvement and successful outcomes for studies/program. In this role, a typical day might include: Establish and implement the global strategy and delivery roadmap for external data acquisition and delivery group to enhance internal capabilities in external data collection and standardization, external data acquisition via APIs and external data/systems integrations, automated data quality control and reconciliation as well as 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, including, but not limited to: central labs, specialty labs, biomarkers, companion diagnostics, digital health wearables, eCOA, IRT, etc. Responsible for the definition of robust functional metrics and KPIs/KQIs to monitor external partners’ performance with respect to quality, compliance with the established SOPs and timely delivery. Champion the use of 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 drug development process. Provide vendor and external partner oversight to ensure the systems, processes and procedures used during participant-level data acquisition, transmission and storage conform with the established Regeneron standards and are of high quality and 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. Perform evaluation of 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.

Requirements

• Leadership experience in External Data Operations or related field, leading small to medium functional groups supporting global data management line function.
• 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).
• 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.
• 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.
• 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.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
• 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.
• Ability to build relationships with key internal and external stakeholders at leadership levels and across levels by negotiating effectively, managing conflicts and collaborating successfully.
• Proven ability to lead global teams with a focus on transformation, innovation and operational excellence.
• Excellent interpersonal, oral, and written communication skills.
• Ability to adjust in a fast-paced environment.
• A Bachelor's degree required, advanced degree preferred.
• 15+ years of clinical data management experience in a pharmaceutical or biotech setting.
• 10+ years of functional leadership
• 8+ years people management, leadership and mentoring experience

Responsibilities

• Establish and implement the global strategy and delivery roadmap for external data acquisition and delivery group to enhance internal capabilities in external data collection and standardization, external data acquisition via APIs and external data/systems integrations, automated data quality control and reconciliation as well as 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, including, but not limited to: central labs, specialty labs, biomarkers, companion diagnostics, digital health wearables, eCOA, IRT, etc.
• Responsible for the definition of robust functional metrics and KPIs/KQIs to monitor external partners’ performance with respect to quality, compliance with the established SOPs and timely delivery.
• Champion the use of 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 drug development process.
• Provide vendor and external partner oversight to ensure the systems, processes and procedures used during participant-level data acquisition, transmission and storage conform with the established Regeneron standards and are of high quality and 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.
• Perform evaluation of 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.

Benefits

• comprehensive benefits, which vary by location
• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Director