Director, Clinical Program Quality

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Job Description

About the role:

As the Director, Clinical Program Quality, you will shape and lead a proactive, risk-based quality management strategy across clinical assets, driving exceptional clinical program performance, strengthening regulatory confidence, and accelerating time to market through the early identification and mitigation of systemic compliance risks. You will serve as a trusted strategic advisor within key asset-level governance forums, including the Global Program Team, Clinical Sub-Team, and Clinical Review Board, providing objective guidance on emerging risks, critical quality issues, and mitigation strategies that protect program continuity and maximize asset value. You will lead real-time inspection readiness across all Study Execution Teams, fostering operational excellence, cross-functional collaboration, and sustained compliance with global GCP and regulatory requirements throughout the clinical trial lifecycle. By championing a culture of accountability, scientific rigor, and quality by design, you will influence senior leaders and strategic partners to embed robust quality practices that safeguard patient safety, ensure data integrity, and support successful regulatory submissions around the world. You will report into the Head of Clinical Program Quality, Gastrointestinal and Inflammation.

How you will contribute:

• Develop and execute proactive, risk-based quality management strategies across assigned clinical development assets to strengthen compliance, reduce risk, and enhance overall program performance
• Provide strategic quality leadership by elevating critical quality issues, emerging risks, and mitigation plans to governance bodies, enabling informed, patient-centered, and data-driven decision making
• Lead investigations of Serious Breaches (GCP), scientific misconduct, and other significant quality events, applying robust root cause analysis and driving sustainable corrective and preventive actions
• Drive end-to-end inspection readiness across assigned clinical programs, embedding quality oversight and sustainable compliance throughout the clinical trial lifecycle
• Shape and execute global GCP inspection strategies, leading preparation for regulatory inspections and serving as a clinical program quality subject matter expert during health authority interactions
• Design and implement risk-based audit strategies that enable the early identification of quality concerns and proactive mitigation of clinical program risks
• Mentor and support Clinical Program Quality team members and Study Execution Teams, strengthening quality oversight capabilities, documentation excellence, proactive compliance, and cross-functional resolution of quality events
• Advance continuous improvement across R&D Quality by sharing insights, best practices, and lessons learned to enhance quality, performance, and operational excellence across Clinical Trial Delivery and Pharmacovigilance

Skills and qualifications:

• Scientific or allied health/medical degree (BSc required; MSc or PhD preferred)
• 10+ years of progressive experience in the global pharmaceutical industry, including at least 5 years in Quality and/or Compliance supporting clinical development programs
• Advanced expertise across the clinical development lifecycle, from R&D through commercialization and lifecycle management, with deep, hands‑on knowledge of GCP regulations and guidelines
• Experience in quality leadership roles, including quality systems oversight, clinical portfolio governance, audit programs, global regulatory inspection management, and complex investigation and remediation activities

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

Boston, MA

U.S. Base Salary Range:

$177,000.00 - $278,080.00

The estimated salary range reflects an anticipated range for this position. The actual base sa