Head of Clinical Development – Operations Quality

• Define and execute Pfizer’s long-term GCP quality, compliance and integrity strategy for Clinical Development & Operations
• Own the enterprise framework for assessing and communicating the state of GCP quality
• Translate quality intelligence into strategic recommendations for CD&O and R&D leadership
• Design and lead an integrated, risk-based GCP quality-governance model
• Chair the GCP Quality Oversight Committee and elevate material risks and remediation priorities
• Exercise independent judgment and constructive challenge on high-risk clinical-development and business decisions
• Provide strategic quality oversight across the global Phase I-IV portfolio
• Ensure inspection readiness for pivotal trials, submissions and major regulatory interactions
• Identify, investigate and sustainably remediate significant quality issues
• Define the framework for responsible design, validation, deployment and lifecycle management of AI-enabled and digital capabilities
• Sponsor modernization of quality intelligence through integrated data, predictive indicators, automation and AI-enabled insights
• Embed quality by design and proactive risk management into portfolio planning, protocols, study execution, vendor models and technology transformation
• Set quality strategy and risk frameworks for CROs, vendors, sites, strategic partners and other third parties
• Establish GCP quality approaches for acquisitions, integrations and new operating models
• Represent Pfizer with regulators, industry bodies and strategic partners
• Lead systemic quality remediation and enterprise learning from quality events, audits, inspections and near misses
• Lead and develop a globally distributed organization of senior quality leaders and professionals
• Own organizational, skills, succession, workforce, technology and sourcing strategy for CD&O Quality
• Set resource and investment priorities and allocate quality expertise based on enterprise risk and strategic value
• Report to the Head of Clinical Development & Operations and serve on the CD&O Leadership Team

Requirements

• 12+ years of advanced scientific, medical, pharmacy, regulatory, quality or related degree, or equivalent depth of relevant professional experience
• Extensive progressive leadership experience across GCP quality, clinical development, clinical operations, regulatory compliance or related disciplines
• Significant experience leading senior leaders in a complex global organization
• Deep, first-hand expertise in global clinical-trial conduct across Phase I-IV
• Expertise interpreting and applying GCP requirements across major regulatory jurisdictions
• Demonstrated accountability for enterprise quality strategy, clinical quality systems, portfolio risk management, regulatory inspections and complex remediation
• Proven ability to advise and influence executive leaders on significant regulatory, participant, data-integrity, reputational and business risks
• Demonstrated success leading organizational or operating-model transformation while sustaining quality, compliance and business continuity
• Experience establishing governance, decision rights and accountability across complex global matrix organizations and external partner networks
• Ability to lead through ambiguity, challenge constructively, make enterprise trade-offs and convert complex quality information into clear executive decisions
• Candidates must be authorized to be employed in the U.S. by any employer
• Permanent work authorization in the United States is required
• Preferred: direct engagement with major global health authorities
• Preferred: quality strategy experience for AI, digital technologies, advanced analytics, decentralized or novel trial approaches
• Preferred: acquisitions, integrations, alliances or complex GCP quality and third-party risk experience
• Preferred: external industry leadership through professional bodies, regulatory forums or standards development
• Preferred: global leadership teams, succession pipelines and future-facing quality capabilities
• Preferred: strong business and financial acumen

Core Competencies

Demonstrates extensive expertise in GCP Quality Strategy, Clinical Development, and Regulatory Compliance, with a strong focus on risk management and quality oversight across global clinical trials. Proven ability to lead and influence senior leaders while embedding quality by design and proactive risk management into organizational practices.

Highest-signal resume keywords

• GCP Quality Strategy
• Clinical Development Leadership
• Regulatory Compliance Expertise
• Risk Management
• Global Clinical Trial Conduct

ATS Optimization Keywords

Hard Skills

• GCP Requirements Interpretation
• Clinical Quality Systems
• Portfolio Risk Management
• Regulatory Inspections
• Quality Remediation
• AI-Enabled Quality Strategies
• Digital Technologies
• Advanced Analytics
• Decentralized Trial Approaches
• Governance and Accountability

Soft Skills

• Influencing Executive Leaders
• Leading Through Ambiguity
• Constructive Challenge
• Decision-Making
• Organizational Transformation

Industry Keywords

• Clinical Development
• Quality Compliance
• Global Health Authorities
• Third-Party Risk Management
• Professional Bodies Engagement
• Complex Global Organizations
• Quality Oversight Committee
• Material Risks
• Inspection Readiness
• Workforce Strategy