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

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVES/PURPOSE:

• Shapes, 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.

• Responsible to 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.

• Responsible to drive inspection readiness for assigned asset-level clinical programs in TAU, providing oversight to drive sustainable compliance embedded end to end in clinical programs.

• Responsible to 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.

• Responsible to 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.

• Responsible to 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.

• Responsible to 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, BEHAVIOURAL COMPETENCIES AND SKILLS: 

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

• Minimum of 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.

• Dynamic and adaptable leadership style, combining a strong sense of urgency with the flexibility to operate effectively in fast‑changing, complex environments.

• Strategic, creative, and resourceful, with an entrepreneurial mindset and a willingness to be hands‑o