Director, Clinical Program Quality & Excellence; CPQE), Oncology

Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Program Quality & Excellence (CPQE), Oncology based in Cambridge, MA reporting to the Head, Clinical Program Quality Oncology.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Shape, at the asset-level, a risk based quality management model that elevates clinical program performance, strengthens regulatory confidence, and accelerates time to market by proactively reducing systemic compliance risks.
• Serve as a strategic quality leader at asset-level key governance bodies (e.g. Global Program Team, Clinical Sub-Team, Clinical Review Board), shaping portfolio decision making by providing objective insights on emerging risks, critical quality issues, and mitigation strategies that safeguard program continuity and asset value.
• Lead real time inspection readiness at the asset-level, across all Study Execution Teams, driving operational discipline, cross functional issue resolution, and sustained adherence to global GCP and regulatory expectations throughout end to end clinical trial delivery.
• Champion a culture of accountability, scientific rigor, and quality by design at the asset-level, influencing senior stakeholders and partners to adopt robust quality practices that protect patient safety, uphold data integrity, and support successful regulatory submissions worldwide.

ACCOUNTABILITIES:

• Responsible for quality management for assigned asset-level clinical programs, developing and implementing proactive, risk-based quality management strategies to drive compliance and de-risk clinical programs.
• Lead escalation of quality issues, risks and mitigations to enable data-driven, quality and patient-centric decision-making at relevant governance levels (e.g. Global Program Team, Clinical Sub-Team, Clinical Review Board)
• Lead investigations into Serious Breaches (GCP), Scientific Misconduct, and other significant quality events and deviations, applying robust root cause analysis to ensure effective resolution and prevention of recurrence.
• Drive inspection readiness for assigned asset-level clinical programs in TAU, providing oversight to drive sustainable compliance embedded end to end in clinical programs.
• Lead global GCP inspection strategy for assigned asset-level clinical programs, leading the planning for submission‑related inspections, representing Takeda as a Subject Matter Expert (SME) in clinical program quality oversight during regulatory interactions.
• Develop and implement robust, risk-based audit strategy for assigned asset-level clinical development programs that enables early detection of potential quality issues with appropriate mitigations to reduce clinical program risks.
• Support and mentor the CPQ team for assigned Study Execution Teams (SETs) in the development, implementation and refinement of a proactive quality oversight model, embedding real-time inspection readiness by driving proactive compliance, documentation quality and the framework for proactive investigation and cross‑functional resolution of quality events.
• Contribute to the R&D Quality GxP Center of Continuous Improvement and Performance in CTD and PV through comprehensive approach in sharing insights and learnings throughout clinical program delivery.

EDUCATION AND EXPERIENCE:

• Scientific or allied health/medical degree (BSc required; MSc or PhD preferred).
• 10 or more years of progressive experience in the global pharmaceutical industry, including at least 5 years in Quality and/or Compliance supporting clinical development programs.
• Adva…