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

3316 Takeda Development Center Americas•Boston, MA

3d•Hybrid

About The Position

The Gastrointestinal & Inflammation (GI2) Therapeutic Area Head (TAH), Global Medical Safety is responsible for the end-to-end safety and benefit-risk strategy across the Therapeutic Area (TA). This role ensures integrated, science-driven decision-making for GI2 development and marketed products. The TAH defines and drives the global vision for patient safety, aligning it with asset strategy, regulatory expectations, and enterprise priorities. This senior enterprise decision-maker shapes outcomes in Safety Board and executive governance forums, influencing go/no-go decisions, labeling, and development strategy. Additionally, the TAH builds and leads a high-performing safety organization, fostering innovation and strengthening global capabilities in safety science and benefit-risk assessment.

Requirements

Medical Degree (M.D. or D.O.) required or internationally recognized equivalent ideally combined with Advanced Degree (e.g. Ph.D./Master in a healthcare or Public Health discipline).
Direct clinical patient care experience following post-graduate training and appropriate grounding and knowledge of general medicine.
10 years+ experience gained in Pharmacovigilance, Clinical Research or Clinical Development within Pharmaceutical industry and/or academia and/or CRO including significant experience in operating in a global pharmacovigilance organization.
Minimum of 3 years’ experience in people management.
Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug safety methodologies.
Ability to comprehend and synthesize complex data and should have experience in the identification, analysis and implementation of programs and procedures required to achieve corporate objectives.
Experience of operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.
Experience working in an outsourced environment managing suppliers, CROs, vendors and strategic partnerships.
Identifies opportunities and anticipates changes in the medical safety landscape through an understanding and ongoing assessment of the environment affecting Patient.
Develops partnerships with internal and external stakeholders’ strategic objectives.
Inspires commitment through a wide range of communication channels (meetings, writing, presentations) and demonstrates integrity.
Must have demonstrable experience in people management at a leadership level and well-developed skills in teambuilding, motivating, empowering and developing people.
Works productively in a fast moving and pressured environment.
Good analytical/judgment capabilities to understand, analyze/synthesize and communicate successfully and concisely.
Well-developed time management skillset to assist prioritization of multiple issues.
Computer literate, including safety database acumen.
Self-resourced, with confidence to take the initiative and act autonomously.
Facilitates and efficiently leads meetings, both in person and other media.
Excellent communication skillset, orally and presentational.
Proven ability to work globally and cross-functionally, with strong interpersonal skills /appropriately assertive /team minded and mentoring.

Responsibilities

Owns and is ultimately accountable for the TA-wide benefit–risk profile, integrating internal and external data to drive clear, evidence-based decisions impacting development strategy and regulatory positioning.
Leads interpretation of complex safety signals and emerging risks, directing proactive and reactive response strategies, while overseeing Safety Management Teams (SMTs) and ensuring GSLs proactively identify risks and drive aligned, forward-looking safety recommendations across programs.
Shapes enterprise-level decisions (e.g., go/no-go, study design, risk tolerance, labeling), ensuring the primacy of patient safety while balancing scientific and business considerations.
Plays a central leadership role at Safety Board and other enterprise bodies, ensuring clear, decision-ready safety narratives and recommendations while driving cross-functional alignment.
Leads high-impact regulatory interactions, including direct engagement with Health Authorities on complex safety and benefit–risk matters, anticipating regulatory implications and shaping response strategies.
Leads and develops a multi-layered organization (EMDs, SMDs, GSLs, PV Scientists) with full accountability for talent strategy, organizational design, and succession planning.
Establishes a culture of accountability, scientific rigor, and innovation, ensuring consistent excellence in safety strategy and execution across the TA.
Drives capability advancement, including adoption of advanced analytics, and AI-enabled approaches.
Mentors and develops GSLs and PV Scientists, strengthening medical judgment and advancing scientific safety leadership across the organization.
Serves as the primary safety leader interfacing with cross-functional partners, ensuring integrated product strategy across the lifecycle.
Represents the organization externally with regulatory authorities, advisory boards, and partners, influencing external safety and benefit–risk positioning.
Leads or oversees safety due diligence for business development, ensuring robust evaluation and integration of safety considerations into partnerships.
Ensures excellence in core pharmacovigilance activities (signal detection, risk management, regulatory submissions), with focus on strategic interpretation and impact.
Ensures high-quality safety contributions to global regulatory submissions and health authority interactions, supporting development and lifecycle management.
Ensures compliance with global pharmacovigilance regulations and standards (e.g., FDA, EMA, PMDA, ICH, CIOMS), maintaining inspection readiness.
Core member of the PSPV Leadership Team, contributing to strategic direction and operational excellence.
Leads and/or contributes to executive initiatives across disciplines and functions, driving enterprise impact.