Director of Performance Excellence leading performance improvement projects across a multi - state healthcare system. Collaborating with cross - functional leaders to enhance operational efficiency and achieve measurable outcomes.
About the role
- Senior Director leading external data acquisition and delivery to support Regeneron's clinical pipeline. Collaborating with various teams and ensuring high-quality data management for global studies.
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.
- 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)
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