Head, Clinical Operations, Inflammation & Immunology

Role Summary

The Clinical Operations Head (COH) leads the global clinical operations organization accountable for the operational delivery of all global studies in the inflammation and immunology therapeutic category, from first-in-patient to loss of exclusivity. The COH is a member of the Clinical Development & Operations (CD&O) Leadership Team and partners with Pfizer Research and Development leadership within the therapeutic area to prioritize, resource, and deliver the portfolio in line with strategy, timelines, quality standards, and budget. The COH leads a global team across Pfizer sites and virtual locations, guiding data-driven planning and the adoption of digital, AI, and automation-enabled capabilities to improve speed, quality, cost efficiency, and patient experience.

Responsibilities

• Portfolio Delivery and Strategy: 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.
• Portfolio Delivery and Strategy: Partners with the Pfizer Clinical Research Unit Head to support the delivery of first-in-human and clinical pharmacology studies.
• Portfolio Delivery and Strategy: Leverages AI-enabled insights, predictive analytics, and scenario modeling to inform portfolio prioritization, study feasibility, timelines, and resource allocation.
• Portfolio Delivery and Strategy: Influences clinical development strategy, portfolio prioritization, and budget allocation through strong clinical operations leadership and data-driven input.
• Operational Excellence, Risk, and Quality: 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.
• Operational Excellence, Risk, and Quality: 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.
• Operational Excellence, Risk, and Quality: Ensures portfolio deliverables meet or exceed Pfizer and industry-leading standards for quality, speed, and cost.
• Operational Excellence, Risk, and Quality: Maintains inspection readiness at all times and serves as a point of escalation for significant operational or quality issues, including oversight of CAPAs.
• Operational Excellence, Risk, and Quality: Ensures AI-enabled tools used in study oversight, monitoring, or reporting are compliant, explainable, and inspection ready.
• Digital, AI, and Continuous Improvement: Identifies, leads, and implements industry-leading best practices for the conduct of clinical trials, including AI-enabled and data-driven operational innovations.
• Digital, AI, and Continuous Improvement: Drives a culture of continuous improvement, data-driven decision-making, and responsible adoption of AI-enabled ways of working.
• Digital, AI, and Continuous Improvement: Partners with Digital, Data Science, and Quality organizations to ensure responsible, governed, and value-driven use of AI and advanced analytics in clinical operations.
• Leadership and Talent Development: Inspires, motivates, and engages clinical operations colleagues by providing clarity of purpose and setting high expectations for operational excellence.
• Leadership and Talent Development: Develops and executes a talent management strategy that supports leadership development, succession planning, and sustained organizational performance.
• Leadership and Talent Development: Builds organizational AI and data fluency by setting expectations for leaders to appropriately interpret, challenge, and act on AI-generated insights.
• Leadership and Talent Development: Supports the upskilling of CSTLs and operations leaders in data-driven decision-making, digital capabilities, and AI literacy.
• Compliance and Governance: Ensures compliance with all applicable regulatory, operational, and technical requirements, including global and local training requirements and adherence to relevant SOPs.
• Compliance and Governance: Partners with enterprise Digital, Data Science, and AI Governance teams to align clinical operations activities with Pfizer’s AI strategy, data standards, and responsible AI principles.

Qualifications

• 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.

Skills

• Exceptional leadership, communication, and stakeholder management skills.
• Strong AI and data literacy, including understanding AI capabilities, limitations, and implications for clinical operations decision-making (technical model development expertise not required).