Head of Gastrointestinal & Inflammation, Global Medical Safety (Vice President)

Takeda•Boston, MA

14d•$321,000 - $504,460•Hybrid

About The Position

The Head of Gastrointestinal & Inflammation, Global Medical Safety is accountable for end-to-end safety and benefit–risk strategy across the therapeutic area, integrating science-driven decisions across development and marketed products. The role defines the global patient-safety vision in alignment with asset strategies, regulatory expectations, and enterprise priorities, and shapes executive decisions on development strategy, labeling, and go/no-go outcomes. The position leads a multi-layered safety organization and is accountable for talent strategy, organizational design, succession planning, and capability development. It leads safety governance and complex regulatory interactions, serves as the primary safety interface for cross-functional partners, and represents the organization with regulators, advisory boards, and business partners. The role also oversees pharmacovigilance quality, compliance, safety contributions to regulatory submissions, and safety due diligence for business development. It is a core member of the PSPV Leadership Team and contributes to enterprise-wide initiatives.

Requirements

Medical degree (M.D. or D.O.) or internationally recognized equivalent.
Direct clinical patient-care experience following postgraduate training, with an appropriate grounding in and knowledge of general medicine.
At least 10 years of experience in pharmacovigilance, clinical research, or clinical development in pharmaceutical industry, academia, or a CRO, including significant experience in a global pharmacovigilance organization.
At least 3 years of people-management experience.
Demonstrated knowledge of regulatory agency requirements regarding drug safety and understanding of general drug safety methodologies.
Ability to comprehend and synthesize complex data and experience identifying, analyzing, and implementing programs and procedures to achieve corporate objectives.
Experience operating in a multidisciplinary 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.
Demonstrable leadership-level people-management experience and well-developed team-building, motivating, empowering, and people-development skills.
Ability to work productively in a fast-moving, pressured environment.
Strong analytical and judgment capabilities, including the ability to understand, analyze, synthesize, and communicate information concisely.
Well-developed time-management skills and ability to prioritize multiple issues.
Computer literacy, including safety database acumen.
Self-resourcefulness, confidence to take initiative, and ability to act autonomously.
Ability to facilitate and efficiently lead meetings in person and through other media.
Excellent oral and presentation communication skills.
Ability to work globally and cross-functionally, with strong interpersonal skills, appropriate assertiveness, a team-minded approach, and mentoring ability.
Ability to identify opportunities and anticipate changes in the medical safety landscape through ongoing assessment of the environment affecting patients.
Ability to develop partnerships with internal and external stakeholders in support of strategic objectives.
Ability to inspire commitment through a range of communication channels, including meetings, writing, and presentations, and to demonstrate integrity.

Nice To Haves

An advanced degree, such as a Ph.D. or master's degree in a healthcare or public health discipline, ideally in combination with the required medical degree.

Responsibilities

Own the therapeutic area-wide benefit–risk profile, integrating internal and external data to support evidence-based decisions affecting development strategy and regulatory positioning.
Lead interpretation of complex safety signals and emerging risks, direct proactive and reactive responses, and oversee Safety Management Teams.
Shape enterprise decisions on go/no-go outcomes, study design, risk tolerance, and labeling while prioritizing patient safety.
Lead in Safety Board and other enterprise governance forums, providing clear, decision-ready safety narratives and recommendations and driving cross-functional alignment.
Lead high-impact regulatory interactions, including engagement with Health Authorities on complex safety and benefit–risk matters.
Lead and develop a multi-layered organization, with accountability for talent strategy, organizational design, and succession planning.
Build a culture of accountability, scientific rigor, and innovation and advance safety capabilities, including adoption of advanced analytics and AI-enabled approaches.
Mentor and develop GSLs and PV Scientists, strengthening medical judgment and scientific safety leadership.
Serve as the primary safety leader interfacing with cross-functional partners and support integrated product strategy across the lifecycle.
Represent the organization with regulatory authorities, advisory boards, and partners, and lead or oversee safety due diligence for business development.
Ensure excellence in pharmacovigilance activities, including signal detection, risk management, and regulatory submissions.
Ensure high-quality safety contributions to global regulatory submissions and health authority interactions supporting development and lifecycle management.
Ensure compliance with global pharmacovigilance regulations and standards and maintain inspection readiness.
Contribute to the strategic direction and operational excellence of the PSPV Leadership Team and lead or contribute to executive initiatives across functions.
Travel up to 15% domestically and internationally to support transformation activities, governance, inspections, audits, capability-center engagement, and business meetings.