Director, Clinical Data Management Reporting

Regeneron Pharmaceuticals • Armonk, NY

3d

About The Position

The Director of Clinical Data Management Reporting will provide strategic leadership for clinical and external data reporting across clinical development unit (CDU) programs. This role focuses on the creation, standardization, and delivery of clinical data programming, external data reconciliation, and reporting deliverables across portfolio, ensuring alignment with study data review plans (DRP), study milestone needs, operational metrics, and regulatory requirements. The incumbent will be accountable for the oversight and execution of all data management programming deliverables at the portfolio level. Responsibilities include quality and timely delivery of programming outputs such as data review plan listings, exception listings, external data reconciliation reports, operational metrics, and other reports supporting clinical trial quality and risk management. The Director will manage internal teams and external vendors, ensuring study milestones are met while safeguarding data quality, integrity, and compliance with global regulatory standards. The position emphasizes cross-functional collaboration, deep expertise in clinical data programming, external data handling and reconciliation, industry standards, programming methodologies, and clinical data management systems. As a Director, Clinical Data Reporting, a typical day may include: Drive strategic leadership with full accountability for the planning, execution, and delivery of high-quality clinical data management programming deliverables across the portfolio of clinical development units. Provide comprehensive oversight of clinical programming and visualization outputs that reveal key insights to support clinical data review, including data review listings, exception listings, external data reconciliation, operational metrics, and other quality reports and ensure accuracy, reliability, and integrity of data supporting clinical studies across the portfolio. Advance operational excellence by establishing robust data reporting standards, implementing scalable programming strategies, optimizing workflows incorporating automation, and ensuring consistent delivery of high-quality outputs in accordance with defined user requirement specifications. Provide subject matter expertise in advanced clinical data programming, data extraction and transformation, visualization, and emerging technologies to enhance and advance internal data reporting capabilities. Collaborate with clinical data management teams, functional line management, and cross-functional teams to align priorities, streamline workflows, optimize resource allocation, and drive successful delivery of clinical data management programming objectives. Apply quality-by-design principles to all clinical data management programming and reporting deliverables ensuring that high-quality outputs are aligned and consistent with risk-based strategies, and inspection readiness. Lead continuous improvement initiatives to modernize clinical data reporting workflows through standardization, process optimization, and automation to improve programming efficiency and scalability. Proactively identify potential risks to data quality, integrity, and delivery timelines and implement mitigation strategies to ensure continuity, compliance, and successful delivery of programming objectives. Ensure inspection readiness and regulatory compliance of programming documentation; contribute to internal audits and health authority inquiries. Establish and monitor KPIs to track performance, conformance with programming standards, and identify opportunities to enhance and/or optimize reporting capabilities. Responsible for line management and performance of Clinical Data Management Reporting staff, development of competencies and assessment of annual performance. Provide leadership and mentorship to programming teams, fostering skill development, knowledge sharing, and operational excellence. Author and contribute to the development of clinical data management programming and reporting SOPs, WIs and departmental training needs.

Requirements

• Demonstrated ability to oversee the development, validation, and delivery of clinical data management programming and visualization outputs to cross-functional teams across drug development programs.
• Experience in transforming raw clinical data, external data handling, processing, validation, and reconciliation outputs into actionable insights to ensure data accuracy and quality in compliance with industry standards.
• Demonstrated ability to function as a clinical data management programming and reporting SME in solving complex issues and guiding internal teams and external vendors for successful outcomes.
• Demonstrated ability to build relationships and collaborate across diverse business units including Clinical Data Management, Clinical Development, Precision Medicine, Imaging, and GDIT.
• Expertise in managing and reconciling clinical eCRF and external data types including PK, ADA, Biomarker, Imaging, ECG, etc., to ensure data accuracy, integrity, and regulatory compliance.
• Proven experience in clinical data operations, clinical data management, reporting, and analytics within a pharmaceutical, biotech, or clinical research organization.
• Knowledge of clinical data management principles, technologies, data extraction, transformation, and integration, programming methods and techniques, regulations and best practices, including 21 CFR Part 11, ICH-GCP, and CDISC standards -- related to data acquisition, processing, handling, and reporting.
• Knowledge and expertise in industry standard reporting and data visualization tools including SAS, R, JReview, Spotfire, Tableau, Power BI, and R Shiny to drive operational excellence for clinical data management reporting.
• Excellent interpersonal, oral, and written communication skills.
• Ability to adjust in a fast-paced environment.
• May require up to 25% travel.
• BS/MS + 12+ years leadership experience

Responsibilities

• Drive strategic leadership with full accountability for the planning, execution, and delivery of high-quality clinical data management programming deliverables across the portfolio of clinical development units.
• Provide comprehensive oversight of clinical programming and visualization outputs that reveal key insights to support clinical data review, including data review listings, exception listings, external data reconciliation, operational metrics, and other quality reports and ensure accuracy, reliability, and integrity of data supporting clinical studies across the portfolio.
• Advance operational excellence by establishing robust data reporting standards, implementing scalable programming strategies, optimizing workflows incorporating automation, and ensuring consistent delivery of high-quality outputs in accordance with defined user requirement specifications.
• Provide subject matter expertise in advanced clinical data programming, data extraction and transformation, visualization, and emerging technologies to enhance and advance internal data reporting capabilities.
• Collaborate with clinical data management teams, functional line management, and cross-functional teams to align priorities, streamline workflows, optimize resource allocation, and drive successful delivery of clinical data management programming objectives.
• Apply quality-by-design principles to all clinical data management programming and reporting deliverables ensuring that high-quality outputs are aligned and consistent with risk-based strategies, and inspection readiness.
• Lead continuous improvement initiatives to modernize clinical data reporting workflows through standardization, process optimization, and automation to improve programming efficiency and scalability.
• Proactively identify potential risks to data quality, integrity, and delivery timelines and implement mitigation strategies to ensure continuity, compliance, and successful delivery of programming objectives.
• Ensure inspection readiness and regulatory compliance of programming documentation; contribute to internal audits and health authority inquiries.
• Establish and monitor KPIs to track performance, conformance with programming standards, and identify opportunities to enhance and/or optimize reporting capabilities.
• Responsible for line management and performance of Clinical Data Management Reporting staff, development of competencies and assessment of annual performance.
• Provide leadership and mentorship to programming teams, fostering skill development, knowledge sharing, and operational excellence.
• Author and contribute to the development of clinical data management programming and reporting SOPs, WIs and departmental training needs.

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
• Number of Employees: 5,001-10,000 employees