Head, Clinical Development & Operations Quality
Pfizer
September 01, 2026
Remote friendly (New York, NY)
United States
Clinical Research and Development
Job Responsibilities
- Set and execute the long-term GCP quality, compliance and integrity strategy for CD&O.
- Own the enterprise framework to assess, communicate and improve the state of GCP quality (leading/lagging indicators, regulatory expectations, audit/inspection outcomes, quality-event trends).
- Translate quality intelligence into strategic recommendations for portfolio priorities, operating-model design, capability investment, resourcing and risk acceptance.
- Design and lead an integrated, risk-based GCP quality-governance model with clear decision rights, escalation thresholds and accountability.
- Chair the GCP Quality Oversight Committee and elevate material risks and remediation priorities to executive governance bodies.
- Exercise independent judgment and challenge decisions that could compromise participant protection, data integrity, regulatory compliance, or Pfizer’s ability to defend evidence.
- Provide strategic quality oversight across the global Phase I-IV portfolio; focus on greatest participant/data-integrity/regulatory/business risk.
- Ensure inspection readiness for pivotal trials/submissions; act as senior CD&O quality representative in sponsor inspections and regulatory engagements.
- Lead AI/digital quality: define frameworks for design/validation/deployment/lifecycle management; partner to ensure explainability, data integrity, risk controls and regulatory readiness; modernize quality intelligence with data/AI.
- Embed quality by design across planning, protocol/operations, vendor models and technology transformation.
- Establish third-party, CRO/vendor and partner GCP quality strategy; lead risk-based due diligence, contracting expectations and oversight.
- Provide executive leadership for systemic remediation and organizational learning.
- Lead globally distributed quality organization, capability/talent strategy, resource/investment prioritization, and a culture of integrity and accountable delivery.
Qualifications / Skills
- 12+ years’ advanced scientific/medical/pharmacy/regulatory/quality experience (or equivalent).
- Extensive progressive leadership in GCP quality, clinical development/operations, and regulatory compliance; experience leading senior leaders in a complex global organization.
- Deep expertise in Phase I-IV clinical trial conduct and application of GCP requirements across major jurisdictions.
- Demonstrated enterprise accountability for quality strategy, clinical quality systems, portfolio risk management, inspections and complex remediation.
- Proven ability to advise/influence executives on high-stakes regulatory/participant/data-integrity/reputational/business risk.
- Demonstrated success transforming organizational/operating models while sustaining quality and compliance.
- Experience establishing governance/decision rights across matrix organizations and external partner networks.
- Ability to lead through ambiguity, challenge constructively, make trade-offs, and convert complex quality information into executive decisions.
Preferred Qualifications
- Direct experience engaging major global health authorities on inspections and evolving GCP expectations.
- Experience shaping quality strategy for AI/digital/advanced analytics, decentralized or novel trial approaches.
- Experience with acquisitions/integrations/alliances introducing third-party and GCP quality risk.
- External industry leadership (forums/standards/thought leadership).
- Track record building global leadership teams and future-facing capabilities.
- Strong business/financial acumen (resource prioritization and investment decisions).
Benefits (explicitly stated)
- Annual base salary: $300,100.00–$500,100.00; Global Performance Plan bonus target 30% of base; share-based long-term incentive eligible.
- 401(k) with Pfizer matching + additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
- Relocation assistance may be available (business needs/eligibility).
Application Instructions
- Candidates must be authorized to work in the U.S.; U.S. work visa sponsorship is not available for this role (now or in the future).
- Set and execute the long-term GCP quality, compliance and integrity strategy for CD&O.
- Own the enterprise framework to assess, communicate and improve the state of GCP quality (leading/lagging indicators, regulatory expectations, audit/inspection outcomes, quality-event trends).
- Translate quality intelligence into strategic recommendations for portfolio priorities, operating-model design, capability investment, resourcing and risk acceptance.
- Design and lead an integrated, risk-based GCP quality-governance model with clear decision rights, escalation thresholds and accountability.
- Chair the GCP Quality Oversight Committee and elevate material risks and remediation priorities to executive governance bodies.
- Exercise independent judgment and challenge decisions that could compromise participant protection, data integrity, regulatory compliance, or Pfizer’s ability to defend evidence.
- Provide strategic quality oversight across the global Phase I-IV portfolio; focus on greatest participant/data-integrity/regulatory/business risk.
- Ensure inspection readiness for pivotal trials/submissions; act as senior CD&O quality representative in sponsor inspections and regulatory engagements.
- Lead AI/digital quality: define frameworks for design/validation/deployment/lifecycle management; partner to ensure explainability, data integrity, risk controls and regulatory readiness; modernize quality intelligence with data/AI.
- Embed quality by design across planning, protocol/operations, vendor models and technology transformation.
- Establish third-party, CRO/vendor and partner GCP quality strategy; lead risk-based due diligence, contracting expectations and oversight.
- Provide executive leadership for systemic remediation and organizational learning.
- Lead globally distributed quality organization, capability/talent strategy, resource/investment prioritization, and a culture of integrity and accountable delivery.
Qualifications / Skills
- 12+ years’ advanced scientific/medical/pharmacy/regulatory/quality experience (or equivalent).
- Extensive progressive leadership in GCP quality, clinical development/operations, and regulatory compliance; experience leading senior leaders in a complex global organization.
- Deep expertise in Phase I-IV clinical trial conduct and application of GCP requirements across major jurisdictions.
- Demonstrated enterprise accountability for quality strategy, clinical quality systems, portfolio risk management, inspections and complex remediation.
- Proven ability to advise/influence executives on high-stakes regulatory/participant/data-integrity/reputational/business risk.
- Demonstrated success transforming organizational/operating models while sustaining quality and compliance.
- Experience establishing governance/decision rights across matrix organizations and external partner networks.
- Ability to lead through ambiguity, challenge constructively, make trade-offs, and convert complex quality information into executive decisions.
Preferred Qualifications
- Direct experience engaging major global health authorities on inspections and evolving GCP expectations.
- Experience shaping quality strategy for AI/digital/advanced analytics, decentralized or novel trial approaches.
- Experience with acquisitions/integrations/alliances introducing third-party and GCP quality risk.
- External industry leadership (forums/standards/thought leadership).
- Track record building global leadership teams and future-facing capabilities.
- Strong business/financial acumen (resource prioritization and investment decisions).
Benefits (explicitly stated)
- Annual base salary: $300,100.00–$500,100.00; Global Performance Plan bonus target 30% of base; share-based long-term incentive eligible.
- 401(k) with Pfizer matching + additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
- Relocation assistance may be available (business needs/eligibility).
Application Instructions
- Candidates must be authorized to work in the U.S.; U.S. work visa sponsorship is not available for this role (now or in the future).