Director, Clinical Program Quality

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 and 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 to embed robust quality practices that safeguard patient safety, ensure data integrity, and support successful regulatory submissions around the world. You will report to the Head of Clinical Program Quality, Gastrointestinal and Inflammation.

• 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 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

• 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

Location:

Boston, MA

U.S. Base Salary Range: $ – $

U.S. based employees may be eligible for short-term and long-term incentives, a 401(k) plan with company match, medical, dental, vision insurance, short-term and long-term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits. U.S. based employees are also eligible to receive up to 80 hours of sick time per calendar year, and new hires may accrue up to 120 hours of paid vacation.

Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.