SSO Study Start - Up Manager guiding study planning and activation deliverables across various regions. Ensures compliance with regulatory requirements and collaboration with global study teams.
About the role
- Head of Clinical Operations leading global clinical studies and regulatory submissions for Pfizer in Inflammation & Immunology. Overseeing operational delivery and strategic direction with an emphasis on quality and innovation.
Responsibilities
- Serves as the single point of accountability for the operational delivery of the portfolio of clinical studies and regulatory submissions in alignment with clinical development plans
- Partners with the Pfizer Clinical Research Unit Head to support the delivery of first-in-human and clinical pharmacology studies
- Leverages AI-enabled insights, predictive analytics, and scenario modeling to inform portfolio prioritization, study feasibility, timelines, and resource allocation
- Influences clinical development strategy, portfolio prioritization, and budget allocation through strong clinical operations leadership and data-driven input
- Ensures risk management and mitigation strategies are established and implemented across all studies, including the use of advanced analytics and AI-supported risk detection where appropriate
- Holds CSTLs accountable for leading study teams through all stage gates and for the quality and accuracy of operational data used for performance reporting
- Ensures portfolio deliverables meet or exceed Pfizer and industry-leading standards for quality, speed, and cost
- Maintains inspection readiness at all times
Requirements
- Bachelor’s degree required
- Advanced degree or professional certification in a healthcare-related, scientific, or technical discipline preferred
- Minimum of 15 years of experience with a strong track record of success in clinical research and development within the biopharmaceutical industry
- Extensive knowledge of clinical development, global and regional regulations, ICH/GCP, and adverse event management
- Demonstrated experience leading large, complex organizations and developing senior clinical operations leaders
- Proven experience leading or sponsoring data-driven, digital, or AI-enabled transformation initiatives in clinical development or clinical operations
- Strong ability to translate advanced analytics and AI insights into operational and strategic decisions
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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