Regeneron · 1 day ago
Director, Clinical Data Management Reporting
Warren, NJ
Full-time
Onsite
Director/Executive
$183K/yr - $305K/yr
12+ years expRegeneron is a leading biotechnology company focused on developing innovative medicines. The Director of Clinical Data Management Reporting will provide strategic leadership for clinical and external data reporting, ensuring the quality and timely delivery of programming outputs and overseeing clinical data management programming deliverables at the portfolio level.
BiopharmaBiotechnologyPharmaceutical
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
Qualification
Required
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
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)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase