Director, Clinical Program Quality

Takeda Pharmaceutical Company Limited; Boston (MA); On-site; USD 177,000 - 278,080; Full time

Job summary

JobRx, Inc. in Boston, MA is seeking a Director of Clinical Program Quality to shape and lead risk-based quality management across clinical assets, driving program performance, regulatory confidence, and timely market approvals.

Lead governance forums, manage investigations, and drive inspection readiness while embedding quality by design throughout the trial lifecycle. This role reports to the Head of Clinical Program Quality.

Qualifications

• Bachelor's degree in a scientific or allied health/medical field.
• 10+ years 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 with deep knowledge of GCP regulations and guidelines.
• Experience in quality leadership roles, including audit programs and regulatory inspection management.

Responsibilities

• Develop and execute proactive, risk-based quality management strategies across assigned clinical development assets.
• Provide strategic quality leadership by elevating critical quality issues and mitigation plans to governance bodies.
• Lead investigations of Serious Breaches (GCP), scientific misconduct, and other significant quality events with root cause analysis.
• Drive end-to-end inspection readiness across assigned clinical programs and lifecycle.
• Shape and execute global GCP inspection strategies for regulatory interactions.
• Design risk-based audit strategies to identify quality concerns early and mitigate risks.
• Mentor Clinical Program Quality team members and Study Execution Teams.
• Advance continuous improvement across R&D Quality and Pharmacovigilance.

Skills

Quality leadership

GCP regulations knowledge

Regulatory inspections knowledge

Education

BSc required (scientific/medical)

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.

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

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.

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.