Senior Director, Data Management Portfolio Delivery - Oncology/Hematology

Role Summary

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.

Responsibilities

• 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.

Qualifications

• Required: 15+ years of clinical data management experience in a pharmaceutical or biotech setting
• Required: 10+ years of functional leadership
• Required: 8+ years of people management, leadership and mentoring experience
• Required: Leadership experience in Clinical Data Management or related field, leading midsized global data management groups across various therapeutic areas
• Required: 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)
• Required: 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
• Required: Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry
• Required: 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
• Required: 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
• Required: Proven ability to establish highly motivated and performing teams with a focus on transformation, innovation and operational excellence
• Required: Excellent interpersonal, oral, and written communication skills
• Required: Ability to adjust in a fast-paced environment

Education

• Required: Bachelor's Degree
• Preferred: Advanced degree

Additional Requirements

• May require up to 25% travel