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.

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)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data managementdata acquisitiondata standardizationautomationAI solutionscloud ecosystemsdata integrationsbusiness intelligence solutionsclinical data systemsdata normalization

Soft Skills

leadershippeople managementmentoringcross-functional collaborationcommunicationrisk mitigationstrategic initiative leadershiprelationship buildingproblem-solvingoperational excellence