Clinical Operations Lead
hace 2 semanas
About the Role
The VP of Clinical Operations in the CMAO RWE Platform leads a global Clinical Operations organization to support the implementation of observational Pfizer enterprise evidence generation and all Medical Affairs RWE research agendas across all categories and all regions, IDM, EM, and China.
Key Responsibilities
- Leads a global Clinical Operations organization to support the implementation of observational Pfizer enterprise evidence generation and all Medical Affairs RWE research agendas.
- Oversees operational support for work from PRD and other areas of Pfizer, including a broad portfolio of regulatory submission studies for label change, committed PASS, PMS, HTA requirements, and post-marketing commitments.
- Conducts studies to support the Integrated Evidence Plans (IEP) and strategic goals of all regions, including IDM and EM.
- Partners with other RWE Platform VP lines, Category CMAOs, Platform CMAOs, Enterprise VP and Presidents, Medical Affairs leads, Safety, CD&O, PRD, GSSO, and other leaders in early and late phase development, Global Health & Value to develop and execute strategies to deliver the IEP study deliverables.
- Responds to the dynamic business needs to ensure appropriate resourcing across all assets and regions to deliver innovative, high-quality, cost-efficient, clinical, and epidemiological studies.
- Provides guidance and oversight of Clinical Operations activities for all TAs, with each TA Clinical Operations Head reporting to the C&O VP.
- Collaborates with the RWE Platform Quality and Compliance group to establish global consistency, governance, and compliance by developing fit-for-purpose training, oversight, processes/procedures, and updating existing SOPs to adjust for innovation and high-quality evidence generation.
- Builds and continuously improves the delivery of high-quality, efficient, and consistent evidence generation across the Pfizer enterprise for the main customers, including CMAO, PRD, GAV, and CAI.
Requirements
- Determine the needs of TAs/CMAOs/International and work cross-functionally to build the Evidence Generation machinery to provide world-class medical data.
- Oversee the Clinical Operations groups to execute and deliver high-quality studies in accordance with category priority.
- Lead core study teams, generation, and approval of study documents, protocol development/approval, provide operational support as per study type (SOP), and needs.
- Control budget and timelines of program activities and ensure adherence to the highest quality and compliance standards in accordance with Pfizer SOPs.
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