Senior Director, Data Management Portfolio Delivery – Oncology/Hematology

Role Overview

• Lead, manage and develop a team of highly engaged data managers and portfolio leads
• 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)
• Ensure fit-for-purpose clinical data and compliance with Regeneron procedures and applicable regulatory requirements
• 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
• Contribute to the overall vision, direction and strategy for Data Management line function
• Monitor group’s performance with respect to quality, adherence to standards, compliance with the established SOPs, WIs and applicable regulations
• Proactively identify issues and propose solutions to mitigate operational risks and/or escalations for the function
• Lead strategic cross-functional initiatives to promote increased process efficiency and operational excellence
• Author and contribute to the development of global clinical data management SOPs/WIs and corresponding departmental training curricula

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.

Tech Stack

• Google Cloud Platform

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) for eligible employees at all levels