Senior Director, External Data Acquisition – Delivery

Role Overview

• 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.
• 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.
• 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

• 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
• 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).
• 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.
• 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.

Tech Stack

• Cloud
• Google Cloud Platform

Benefits

• 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)