Gastrointestinal & Inflammation (GI2) Therapeutic Area Head (TAH), Global Medical Safety

About the role

Principal responsibilities include leading the end-to-end safety and benefit–risk strategy across the Therapeutic Area (TA), ensuring integrated, science-driven decision-making for GI2 development and marketed products. This role defines and drives the global vision for patient safety, aligning safety strategy with asset strategy, regulatory expectations, and enterprise priorities. The position serves as a senior enterprise decision-maker, shaping outcomes in Safety Board and executive governance forums, including impact on go/no-go decisions, labeling, and development strategy.

Responsibilities

• Own and drive the TA-wide benefit–risk profile, integrating internal and external data to inform development strategy and regulatory positioning.
• Lead interpretation of complex safety signals and emerging risks, directing proactive and reactive response strategies while overseeing Safety Management Teams (SMTs).
• Shape enterprise-level decisions (e.g., go/no-go, study design, risk tolerance, labeling) with a focus on patient safety while balancing scientific and business considerations.
• Play a central leadership role in Safety Board and other enterprise bodies, ensuring clear, decision-ready safety narratives and cross-functional alignment.
• Lead high-impact regulatory interactions, including direct engagement with Health Authorities on complex safety and benefit–risk matters.
• Build and lead a high-performing safety organization, with accountability for talent strategy, organizational design, and succession planning.
• Establish a culture of accountability, scientific rigor, and innovation in safety strategy and execution across the TA.
• Drive capability advancement, including adoption of advanced analytics and AI-enabled approaches.
• Mentor and develop GSLs and PV Scientists to strengthen medical judgment and scientific safety leadership.
• Serve as the primary safety leader interfacing with cross-functional partners to ensure integrated product strategy across the lifecycle.
• Represent the organization externally with regulatory authorities, advisory boards, and partners, influencing external safety and benefit–risk positioning.
• Lead or oversee safety due diligence for business development, ensuring robust evaluation and integration of safety considerations into partnerships.
• Ensure excellence in core pharmacovigilance activities (signal detection, risk management, regulatory submissions) with a focus on strategic interpretation and impact.
• Ensure high-quality safety contributions to global regulatory submissions and health authority interactions.
• Maintain compliance with global pharmacovigilance regulations and standards (e.g., FDA, EMA, PMDA, ICH, CIOMS) and inspection readiness.
• Contribute to the PSPV Leadership Team, shaping strategic direction and operational excellence.
• Lead and contribute to executive initiatives across disciplines and functions, driving enterprise impact.

Requirements

• Medical Degree (M.D. or D.O.) required or internationally recognized equivalent, ideally combined with an Advanced Degree (e.g., Ph.D./Master in healthcare or Public Health).
• Direct clinical patient care experience following post-graduate training and a strong grounding in general medicine.
• 10+ years of experience in Pharmacovigilance, Clinical Research, or Clinical Development within the pharmaceutical industry, academia, or CRO, including significant experience in a global pharmacovigilance organization.
• Minimum of 3 years’ experience in people management.
• Demonstrated knowledge of regulatory agency requirements regarding drug safety and understanding of general drug safety methodologies.
• Ability to comprehend and synthesize complex data, with experience in identifying, analyzing, and implementing programs to achieve corporate objectives.
• Experience operating in a multi-disciplinary drug development environment, including international exposure and experience across therapeutic areas.
• Experience working in an outsourced environment, managing suppliers, CROs, vendors, and strategic partnerships.
• Proven ability to anticipate changes in the medical safety landscape through ongoing assessment of the environment affecting patient safety.
• Strong partnership-building skills with internal and external stakeholders to align with strategic objectives.
• Demonstrable experience in people management at a leadership level, with well-developed skills in team-building, motivating, empowering, and developing people.
• Ability to work productively in a fast-moving, pressured environment.
• Strong analytical and judgment capabilities to understand, analyze, synthesize, and communicate complex information concisely.
• Well-developed time management skills to prioritize multiple issues effectively.
• Computer literacy, including proficiency with safety databases.
• Self-resourced with confidence to take initiative and act autonomously.
• Excellent facilitation and leadership skills for meetings, both in-person and virtual.
• Strong communication skills, both oral and presentational, with a proven ability to work globally and cross-functionally.

Travel Requirements

Up to 15% domestic and international travel may be required to support transformation activities, governance, inspections, audits, capability-center engagement, and business meetings.

Schedule

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Pay

For Location: Boston, MA, the U.S. base salary range is $321,000.00 - $504,460.00. The actual base salary offered may depend on factors such as qualifications, relevant experience, specific skills, education, certifications, and job location.

Benefits

• Eligibility for short-term and/or long-term incentives.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation per year.