Maintenance Director overseeing mechanical systems and quality assurance in assisted living and memory care facility. Review maintenance budgets and collaborate with vendors for cost reduction.
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Onsite Senior Director, Data Management Portfolio Delivery – Oncology/Hematology
Posted 5 days ago
About the role
- Senior Director leading Data Management Portfolio Delivery for Regeneron's Oncology/Hematology areas. Responsible for oversight of clinical data management activities and team leadership in a biotech environment.
Responsibilities
- 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.
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
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