Project Director leading new nuclear generation projects at NextEra Energy. Managing project development from concept through gated milestones in America's largest energy infrastructure developer.
About the role
- Director of Clinical Data Management Reporting at Regeneron providing leadership for clinical data reporting across drug development. Overseeing programming deliverables and ensuring regulatory compliance in a biotech setting.
Responsibilities
- Provide strategic leadership for clinical and external data reporting across clinical development unit (CDU) programs.
- Focus on the creation, standardization, and delivery of clinical data programming, external data reconciliation, and reporting deliverables across portfolio.
- Accountable for the oversight and execution of all data management programming deliverables at the portfolio level.
- Ensure alignment with study data review plans (DRP), study milestone needs, operational metrics, and regulatory requirements.
- Manage internal teams and external vendors, ensuring study milestones are met while safeguarding data quality, integrity, and compliance with global regulatory standards.
- Emphasize cross-functional collaboration, deep expertise in clinical data programming, external data handling and reconciliation, industry standards, programming methodologies, and clinical data management systems.
- 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.
- Establish robust data reporting standards, implement scalable programming strategies, and optimize workflows incorporating automation.
- Lead continuous improvement initiatives to modernize clinical data reporting workflows through standardization, process optimization, and automation.
- Ensure inspection readiness and regulatory compliance of programming documentation; contribute to internal audits and health authority inquiries.
- Establish and monitor KPIs to track performance and conformance with programming standards.
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
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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