Head of Clinical Development – Operations Quality

Jobtailor

Connecticut

On-site

USD 300,000 - 420,000

Full time

8 days ago

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Pfizer seeks a senior GCP Quality leader to set and execute the long-term quality and integrity strategy for Clinical Development & Operations. You will govern risk-based quality frameworks, oversee the Quality Oversight Committee, and drive strategic recommendations to R&D leadership while ensuring readiness for inspections and regulatory interactions.

You will lead a globally distributed team, embedding quality by design and advanced analytics across the portfolio, while partnering with CROs,

Qualifications

12+ years in GCP quality, regulatory compliance, or related field.
Proven leadership across global clinical development and operations.
Experience guiding executive decision-making on regulatory and quality risks.
Track record of enterprise-quality governance and remediation.
Experience with AI/digital quality initiatives is a plus.

Responsibilities

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 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.

Skills

GCP Quality Strategy

Clinical Development Leadership

Regulatory Compliance

Risk Management

Global Clinical Trials

Quality Systems

Audits & Inspections

AI/Analytics in Quality

Vendor Management

Leadership

Education

Advanced degree in life sciences or regulatory

Job description

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