Takeda Pharmaceuticals logo
Takeda Pharmaceuticals

Takeda Pharmaceuticals is a global biopharmaceutical company engaged primarily in the research, development, manufacture, and marketing of pharmaceutical produc

Head, Medical Governance Office

Location

Massachusetts

Posted

74 days ago

Salary

$229.6K - $360.8K / year

Seniority

Lead

No structured requirement data.

Job Description

Head, Medical Governance Office

Takeda Pharmaceuticals

Title: Head, Medical Governance Office locations Boston, MA time type Full time job requisition id R0177340 Job Description: 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. ACCOUNTABILITIES - 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. DIMENSIONS AND ASPECTS - Enterprise level leadership with authority across Global, U.S., Oncology, and International Medical organizations - Comprehensive understanding of the global pharmaceutical landscape, with deep experience in medical affairs combined with strong knowledge of evidence generation methodologies, real‑world data, and post‑marketing commitments. - Operates in a highly regulated, matrixed environment requiring strong judgment, influence, and decision-making under ambiguity - Broad scientific expertise across multiple therapeutic areas, - Balances compliance rigor with innovation enablement, acting as a strategic advisor rather than a procedural gatekeeper - Demonstrated ability to engage credibly with senior internal and external stakeholders, including regulators and auditors - Models ethical leadership, transparency, and accountability Leadership - Demonstrates exceptional ability to lead across a highly diverse portfolio of geographies, cultures, and regulatory environments, inspiring a shared vision and unified medical mindset across International Medical Affairs. - Operates with strong enterprise leadership, effectively influencing senior stakeholders across the International Business Unit and global executive leadership. - Builds trusting, collaborative partnerships with International BU Leaders, General Managers, Global Medical leaders, and LOC Medical Directors, fostering transparency and alignment. - Serves as a role model for Takeda’s values (Patient–Trust–Reputation–Business) and champions a culture of integrity, inclusion, and scientific excellence. Decision-making and Autonomy - As a member of the Global Medical Leadership Team and International BU Executive Team, holds broad decision-making authority for medical strategy, organizational design, talent deployment, and evidence generation priorities across International markets. - Provide strategic leadership of US, OBU, and International BU LOC/Cluster Medical Directors - Risk, Compliance & Ethics: applies responsible AI, data privacy, security, and medical governance principles to all digital initiatives. - Technology & Data Leadership: articulates a compelling digital and AI vision; translates into pragmatic roadmaps and operating mechanisms. - Accountable for medical governance, quality oversight, and compliance across all non‑US LOCs, navigating complex and varied regulatory requirements. - Makes high‑impact decisions that shape global portfolio execution, launch readiness, external engagement strategies, and capability investments across International Medical Affairs. - Ensures timely and informed decision‑making, incorporating diverse insights, rigorous evidence, and multidisciplinary stakeholder input across regions and functions. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Education & Experience - 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 Competencies & Skills - 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 Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. #LI-JT1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $229,600.00 - $360,800.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. 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. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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