Senior Director and Head of Clinical Program Quality

Role Summary

Senior Director and Head of Clinical Program Quality, leading Takeda's global Clinical Programs Quality organization, providing strategic leadership and oversight of clinical development programs, and ensuring risk-based quality interventions and audits are performed for timely mitigations.

Responsibilities

• Leads the global Clinical Programs Quality organization, providing strategic leadership and oversight of the clinical development programs and ensuring risk-based quality interventions and audits are performed for timely mitigations.
• Provide quality oversight of R&D's strategic suppliers and service providers, ensuring outsourced activities are carried out with high quality and compliance.
• Promote inspection readiness for clinical trials and strategic supplier activities, ensuring preparations, management of and response to clinical pre-approval inspections are resourced, prioritized, and expeditiously reported.
• Serve as a senior strategic Quality Partner to relevant R&D stakeholders and strategic suppliers.
• Report to the Head of CPMQ and contribute to the design, implementation and advancement of the CPMQ strategy, model and operations.
• Develop, implement, and refine a proactive quality oversight model for Takeda's clinical development programs and strategic suppliers, ensuring compliance with Takeda standards and applicable regulatory requirements.
• Lead the Clinical Programs Quality function in the development, implementation and refinement of the quality oversight model across the TAUs and Business Units, ensuring regulatory compliance.
• Establish a robust, risk-based audit strategy and framework for clinical development programs, including program- or study-level audits and investigator site audits; communicate critical compliance risks to Management and ensure corrective and preventive actions are implemented.
• Actively participate in R&D’s clinical trial delivery oversight and operating model improvements, championing accountability and continual improvement.
• Identify, investigate and timely mitigate quality issues and risks at development programs and studies; escalate to senior management as needed.
• Establish mechanisms to monitor compliance, issue, and risk management of development programs and strategic suppliers with timely mitigations.
• Analyze information gathered to inform R&D Quality and other stakeholders of actionable insights; promote a state of compliance and share lessons learned across programs.
• Support R&D to be inspection ready with a culture of sustainable compliance; represent Takeda as a clinical quality subject matter expert during health authority inspections; ensure responses are timely and maintain good regulatory standing.
• Provide strategic direction to ensure all clinical inspection commitments are fulfilled on time.
• Serve as a strategic thought partner to the Head of CPMQ on complex problems affecting development activities; consider current and future initiatives, strategies, and budgets.
• Communicate quality or compliance risks and opportunities to GPTs and sub-teams; contribute to the Clinical & Safety Quality Council.
• Lead and participate in governance/quality councils relevant to clinical and supplier activities; contribute to continual improvements.
• Establish Quality Agreements with strategic suppliers and governance meetings (e.g., Quality Management Working Group).
• Ensure robust talent development and succession planning to promote growth and elevate capabilities.

Qualifications

• Scientific or allied health/medical degree (BSc); Masters/PhD preferred.
• Minimum of 12 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 5 years in Quality/Compliance.
• Advanced knowledge of clinical research (GCP), pharmacovigilance (GVP) and medical within R&D and commercialization, and relevant regulations.
• Experience in strategic quality roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigations and remediation, and change management initiatives (e.g., quality system integration, outsourcing strategy).
• Fluency in English (written and spoken); additional languages a plus.

Skills

• Strategic leadership and quality governance
• Risk-based quality management and audits
• Regulatory inspection management and remediation
• Quality systems development and integration
• Vendor management and quality agreements
• Cross-functional collaboration and stakeholder engagement

Education

• Educational background as listed in Qualifications (BSc required; advanced degrees preferred).

Additional Requirements

• Location: USA - MA - Cambridge - Kendall Square - 500