Senior Director, Data Management Portfolio Delivery - Oncology/Hematology

Regeneron Pharmaceuticals • Village of Tarrytown, NY

3d

About The Position

Regeneron is seeking a Senior Director, Data Management Portfolio Delivery for our Oncology/Hematology therapeutic areas. In this role, a typical day might include: The Senior Director, Data Management Portfolio Delivery is a member of the Data Management Senior Leadership Team (DMSLT) and contributes to the vision, direction and strategy of the line function in support of the advancement of Regeneron’s clinical pipeline globally. The incumbent will be responsible for leading, managing and developing a team of highly engaged data managers and portfolio leads. Additionally, this role is accountable for effective oversight and timely delivery of all clinical data management activities from study start-up through archival across multiple studies in one or more therapeutic area(s) ensuring fit-for-purpose clinical data and compliance with Regeneron procedures and applicable regulatory requirements. This position requires advanced knowledge of Electronic Data Capture systems, related applications, industry standards and regulatory requirements as well as progressive experience working on Phase I-IV studies and participating in regulatory submissions and health authority inspections within the medical device and/or pharmaceutical industry. The Senior Director, Data Management Portfolio Delivery will collaborate closely with the Clinical Data Management Central Services, Clinical Data Operations and External Data Acquisition and Delivery Teams along with internal stakeholders and external vendors at different levels to ensure continuous improvement and successful outcomes for studies/programs. This role might be for you if you can/have: Contribute to the overall vision, direction and strategy for Data Management line function and assigned therapeutic area(s). Accountable for operational execution and delivery of quality, fit-for-purpose data in support of statistical analyses across studies within assigned therapeutic area(s); provide comprehensive and effective oversight of FSPs and external partners. Perform evaluation of resource demand and allocation across studies/programs to ensure adequate staffing and high levels of productivity in support of departmental objectives and corporate level portfolio delivery goals; select and recruit top industry talent and provide constructive performance appraisals to ensure professional growth and development. Monitor group’s performance with respect to quality, adherence to standards, compliance with the established SOPs, WIs and applicable regulations; ensure continuous inspection readiness. Proactively identify issues and propose solutions to mitigate operational risks and/or escalations for the function; provide strong leadership support for critical study data management milestones. 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. Liaise with internal and external stakeholders to foster strong relationships and ensure effective cross-functional collaboration and communication throughout drug development process. Author and contribute to the development of global clinical data management SOPs/WIs and corresponding departmental training curricula. Demonstrate company values and act as a role model by promoting competence, collaboration, innovation, respect, ownership and accountability. Maintain awareness of Clinical Data Management emerging trends, technology solutions and industry best practices through peer relationships with thought leaders in the industry; represent Regeneron in professional associations and forums.

Requirements

• Bachelor's Degree required, Advanced degree desirable.
• 15+ years of clinical data management experience in a pharmaceutical or biotech setting.
• 10+ years of functional leadership
• 8+ years of people management, leadership and mentoring experience
• Leadership experience in Clinical Data Management or related field, leading midsized global data management groups across various therapeutic areas.
• Expertise in clinical data management processes, industry best practices and clinical data systems (EDC, eSource, eCOA, IRT, Clinical Data Repository, medical terminology coding solutions, laboratory normal range repositories).
• 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.
• Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry.
• Demonstrated success in solving complex business problems, strategic thinking, organizational design, leading through periods of significant change, i.e., operating model shifts, dynamic portfolio expansion, company and/or asset acquisitions.
• Ability to build relationships with key internal and external stakeholders at leadership levels and across levels by negotiating effectively, managing conflicts, escalations and collaborating successfully.
• Proven ability to establish highly motivated and performing teams with a focus on transformation, innovation and operational excellence.
• Excellent interpersonal, oral, and written communication skills.
• Ability to adjust in a fast-paced environment.
• May require up to 25% travel.

Responsibilities

• Contribute to the overall vision, direction and strategy for Data Management line function and assigned therapeutic area(s).
• Accountable for operational execution and delivery of quality, fit-for-purpose data in support of statistical analyses across studies within assigned therapeutic area(s); provide comprehensive and effective oversight of FSPs and external partners.
• Perform evaluation of resource demand and allocation across studies/programs to ensure adequate staffing and high levels of productivity in support of departmental objectives and corporate level portfolio delivery goals; select and recruit top industry talent and provide constructive performance appraisals to ensure professional growth and development.
• Monitor group’s performance with respect to quality, adherence to standards, compliance with the established SOPs, WIs and applicable regulations; ensure continuous inspection readiness.
• Proactively identify issues and propose solutions to mitigate operational risks and/or escalations for the function; provide strong leadership support for critical study data management milestones.
• 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.
• Liaise with internal and external stakeholders to foster strong relationships and ensure effective cross-functional collaboration and communication throughout drug development process.
• Author and contribute to the development of global clinical data management SOPs/WIs and corresponding departmental training curricula.
• Demonstrate company values and act as a role model by promoting competence, collaboration, innovation, respect, ownership and accountability.
• Maintain awareness of Clinical Data Management emerging trends, technology solutions and industry best practices through peer relationships with thought leaders in the industry; represent Regeneron in professional associations and forums.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Director