Senior Director and Head of Clinical Program Quality

Takeda • Cambridge, MA

60d • Onsite

About The Position

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 Leads the global Clinical Programs Quality organization, establishing a strategic leadership and oversight of the Takeda’s 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. Promotes 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. Serves as a senior strategic Quality Partner to relevant R&D stakeholders and strategic suppliers. Reports to the Head of CPMQ and is a key member of the CPMQ Leadership Team, contributing to the design, implementation and advancement of the CPMQ strategy, model and operations.

Requirements

• 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, preferably with at least 5 years of Quality/Compliance experience.
• Advanced knowledge of clinical research (GCP), pharmacovigilance (GVP) and medical throughout R&D and commercialization, and relevant regulations.
• Preferably with experience in strategic roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigation and remediation activities on a global level and successful management of business transformation/change management initiatives e.g., quality system integration, outsourcing strategy, etc.
• Fluency in written and spoken English, additional language skills a plus.

Responsibilities

• 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.
• Leads the Clinical Programs Quality function in the development, implementation and refinement of a proactive quality oversight model for Takeda’s clinical development programs across the TAUs and Business Units, ensuring compliance with Takeda standards and applicable regulatory requirements.
• Ensures a robust and risk-based audit strategy and framework for the clinical development programs including program- or study-level audits and investigator site audits, is developed and implemented in a timely manner, communicating any critical compliance risks to Management, and ensuring that corrective and preventive actions are implemented.
• Actively participates in Takeda R&D’s clinical trial delivery oversight and operating model improvements and enhancements, championing clear accountabilities, continual improvement and mitigations for past risks.
• Ensures the identification, investigation and timely mitigation of quality issues and risks at the development programs and studies. Escalates these issues and issues to senior management.
• Establish effective mechanisms to monitor compliance, issue, and risk management of development programs and strategic suppliers, ensuring timely mitigations.
• Analyzes information gathered in the oversight of the development programs to inform R&D Quality and other stakeholders of any actionable insights and to promote a state of compliance.
• Ensures knowledge management and lessons learned are shared and applied across development programs.
• Supports R&D to be inspection ready with a culture of sustainable compliance.
• Represents Takeda as a clinical quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda’s good standing with regulatory agencies.
• Ensure that all clinical inspection commitments are fulfilled on time.
• Serve as a strategic thought partner to the Head of CPMQ with regard to complex problems affecting development activities, with an eye to current and future initiatives, strategies, and budgets.
• Ensures any quality or compliance risks and opportunities are communicated to the GPTs and relevant sub-teams, so that the teams are well-informed to make decisions on quality and compliance priorities.
• Contributes to the Clinical & Safety Quality Council.
• Lead and participate in governance/quality councils relevant to clinical and supplier activities, contributing to continual improvements and successes.
• Establishes Quality Agreements with strategic suppliers and and governance meetings e.g., Quality Management Working Group, etc.
• Ensures robust talent development and succession planning measures are in place to promote organizational growth/elevate capabilities.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees