Head, Medical Governance Office

Takeda • Boston, MA

2d • Hybrid

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Head, Medical Governance Office in our Cambridge office. 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 realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. OBJECTIVES/PURPOSE The Head, Medical Governance Office provides enterprise-wide strategic leadership for Medical governance, compliance, and control frameworks across Global, U.S., Oncology, and International Medical organizations. This role ensures inspection ready, risk based, and compliant Medical operations at scale, while enabling innovation through clear standards, fit for purpose controls, and responsible use of data, digital, and AI capabilities. Operating as a key member of the Medical Excellence & Operations leadership team, the role balances regulatory rigor with operational agility, establishing global governance guardrails that accelerate scientific impact while protecting patients, partners, and the company. The position reports to the VP, Head of Medical Excellence & Operations and serves as the primary Medical interface to enterprise Quality, Ethics & Compliance, Legal, Audit, and DD&T functions.

Requirements

• Advanced degree in life sciences, pharmacy, medicine, or related discipline
• 12+ years of experience in Medical Affairs, Medical Operations, Quality, Compliance, or related functions within biopharma
• Deep knowledge of global Medical regulations, inspection readiness, and governance frameworks.
• Prior audit management experience preferred.
• Proven experience leading enterprise governance or risk management programs
• Demonstrated ability to lead through complexity, transformation, and integration across regions with varied maturity levels.
• Strong strategic agility with the ability to connect global strategy to local execution and vice versa.
• Exceptional communication, influence, and relationship building skills across cultures and seniority levels.
• High degree of cultural fluency and sensitivity, with demonstrated success working across Asia, Europe, and emerging markets.
• Strong business acumen and ability to balance strategic priorities with operational realities.
• Commitment to Takeda’s values and to advancing a patient first, ethically grounded medical culture globally

Responsibilities

• Own and continuously evolve the enterprise Medical governance strategy, operating model, and control framework, spanning evidence generation, scientific engagement, patient services, grants and sponsorships, and external data dissemination.
• Define, maintain, and harmonize global Medical SOPs, standards, and minimum required controls, partnering closely with Ethics & Compliance, Quality, Legal, Safety, and Digital to ensure alignment with evolving regulatory expectations.
• Lead enterprise Medical audit and inspection readiness, including proactive risk assessments, mock inspections, evidence room standards, and coordinated inspection response management across all Medical organizations.
• Establish and oversee Medical risk management, issue escalation, and CAPA governance, leveraging data driven monitoring and risk-based oversight to focus resources where risk is highest.
• Provide governance and oversight for Medical grants, sponsorships, and donations, ensuring ethical, compliant, and transparent external funding practices globally.
• Own Medical data governance and knowledge management standards, ensuring data integrity, traceability, privacy, and auditability across Medical systems, analytics, and reporting environments.
• Embed responsible AI and digital governance principles across Medical Operations, balancing innovation speed with regulatory, ethical, and reputational obligations.
• Act as the primary Medical Operations counterpart to enterprise Quality, Ethics & Compliance, Legal, Internal Audit, and Digital leadership, representing Medical perspectives in enterprise forums.
• Advise the Head of Medical Excellence & Operations and Global Medical Leadership Team on emerging regulatory risks, inspection trends, and governance implications of new operating models.

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: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees