Head, Clinical Operations, Inflammation & Immunology

JOB SUMMARY

The Clinical Operations Head (COH) is the leader of a best-in-class clinical operations organization with accountability for the operational delivery of all global clinical studies within a specific therapeutic category, spanning the portfolio from first-in-patient through loss of exclusivity. The role is a member of the Clinical Development & Operations (CD&O) Leadership Team and serves as a key strategic partner to Pfizer Research and Development leadership within the therapeutic area.

The COH ensures that the therapeutic area portfolio is appropriately prioritized, resourced, and delivered in alignment with agreed strategy, timelines, quality standards, and budget. The role leads a global organization of clinical operations leaders and colleagues distributed across Pfizer sites and virtual locations.

The COH is directly accountable to the Head of Clinical Development & Operations for the operational delivery of the therapeutic area portfolio, impacting patients across clinical trial sites worldwide. The role informs, influences, and drives decisions through the application of advanced analytics, AI-enabled insights, and quantitative, data-driven operational planning and execution, and through active leadership in major governance forums.

In close collaboration with peer COHs and functional partners within CD&O, the COH leads the identification, development, and implementation of clinical operations standards, processes, and industry-leading best practices. The COH is accountable for the strategic adoption, scaling, and value realization of digital, artificial intelligence (AI), and automation-enabled capabilities to improve speed, quality, cost efficiency, and patient experience across the portfolio.

The COH sets the highest expectations for quality and operational excellence, fosters a culture of continuous improvement, and inspires Clinical Study Team Leads (CSTLs) to deliver against Pfizer’s strategic imperatives. The role actively develops leadership talent, builds organizational capability, and safeguards the safety and wellbeing of trial participants through robust operational oversight and quality governance.

• 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 (FIH, POC, PSS, DP3, P3, submission) 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 and serves as a point of escalation for significant operational or quality issues, including oversight of CAPAs.
• Ensures AI-enabled tools used in study oversight, monitoring, or reporting are compliant, explainable, and inspection ready.

• Identifies, leads, and implements industry-leading best practices for the conduct of clinical trials, including AI-enabled and data-driven operational innovations.

• Drives a culture of continuous improvement, data-driven decision-making, and responsible adoption of AI-enabled ways of working.
• Partners with Digital, Data Science, and Quality organizations to ensure responsible, governed, and value-driven use of AI and advanced analytics in clinical operations.

• Inspires, motivates, and engages clinical operations colleagues by providing clarity of purpose and setting high expectations for operational excellence.

• Develops and executes a talent management strategy that supports leadership development, succession planning, and sustained organizational performance.
• Builds organizational AI and data fluency by setting expectations for leaders to appropriately interpret, challenge, and act on AI-generated insights.
• Supports the upskilling of CSTLs and operations leaders in data-driven decision-making, digital capabilities, and AI literacy.

• Ensures compliance with all applicable regulatory, operational, and technical requirements, including global and local training requirements and adherence to relevant SOPs.
• Partners with…