Director, Clinical Program Quality

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); On-site; USD 177,000 - 278,000; Full time

Benefits offered by this job

Job summary

Takeda seeks a Director of Clinical Program Quality to lead a proactive, risk-based quality strategy across clinical assets and ensure robust regulatory submission readiness. You will guide governance forums, drive investigations, and champion quality by design to protect patient safety and program value.

You will collaborate with Study Execution Teams and functional partners to embed continuous improvement and compliance across the lifecycle, from development through commercialization,

Qualifications

• Advanced knowledge of GCP regulations and guidelines.
• Experience leading quality systems and regulatory inspections.
• Ability to communicate with senior leadership and drive remediation.

Responsibilities

• Develop and lead proactive, risk-based quality management strategies across clinical development assets.
• Elevate critical quality issues and mitigation plans to governance bodies.
• Lead investigations of Serious Breaches (GCP) and other significant quality events.
• Drive end-to-end inspection readiness across clinical programs.
• Shape global GCP inspection strategies and interact with health authorities.
• Design risk-based audit strategies for early quality issue identification.
• Mentor team members to strengthen quality oversight and cross-functional resolution.
• Share insights to advance continuous improvement across R&D Quality.

Skills

Quality leadership

GCP compliance

Regulatory inspection management

Risk-based quality management

Root cause analysis

Education

Scientific or allied health/medical degree (BSc required; MSc or PhD preferred)

Job description

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 salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in 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.

Locations and Employment Details

Locations Boston, MA

Worker Type Employee

Worker Sub-Type Regular Time Type Full time

Job Exempt Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Company Culture

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.