Head, Clinical Operations, Inflammation & Immunology

Role Summary

The Clinical Operations Head (COH) leads Pfizer's global clinical operations within a specific therapeutic category, ensuring the portfolio is prioritized, resourced, and delivered on strategy, timelines, quality standards, and budget. The COH serves on the Clinical Development & Operations Leadership Team and partners with Pfizer R&D leadership to drive operational excellence and strategic decisions across the therapeutic area. The COH leads a global organization of clinical operations leaders, advances digital and AI-enabled capabilities, and safeguards the safety and wellbeing of trial participants through robust governance and quality oversight.

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 (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 enterprise Digital, Data Science, and AI Governance teams to align clinical operations activities with Pfizer’s AI strategy, data standards, and responsible AI principles.
• Manages an organization of up to 100 colleagues, including people managers and individual contributors.
• Maintains organizational oversight of the clinical operations budget as part of delivering on strategic objectives.
• Interfaces with PRD leaders including the Chief Development Officer, Chief Scientific Officer, Head of Early Clinical Development, Finance, People Experience, Therapeutic Area leadership, and Digital, Data Science, and AI Governance partners.

Qualifications

• Required: Bachelor’s degree.
• Preferred: Advanced degree or professional certification in a healthcare-related, scientific, or technical discipline.
• Required: Minimum of 15 years of experience with a strong track record of success in clinical research and development within the biopharmaceutical industry.
• Required: Extensive knowledge of clinical development, global and regional regulations, ICH/GCP, and adverse event management.
• Required: Demonstrated experience leading large, complex organizations and developing senior clinical operations leaders.
• Required: Proven experience leading or sponsoring data-driven, digital, or AI-enabled transformation initiatives in clinical development or clinical operations.
• Required: 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).