Global VP, GI Safety & Benefit-Risk Strategy

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Hybrid; USD 321,000 - 504,000; Full time

Job summary

Takeda in Boston, MA seeks a Principal Safety leader to own enterprise-wide safety strategy for GI2 development and marketed products. You will influence go/no-go decisions, labeling, and development strategy, shaping regulatory outcomes and building a forward-looking safety organization.

Leading Safety Board discussions and external regulatory interactions, you will drive data-driven risk management, mentor PV scientists, and advance capabilities including analytics and AI-driven safety

Qualifications

• Medical Degree (MD/DO) required or internationally recognized equivalent ideally with an advanced healthcare degree.
• 10+ years in Pharmacovigilance, Clinical Research or Clinical Development in pharma/academia/CRO.
• Minimum of 3 years’ experience in people management.
• Strong knowledge of regulatory agency requirements for drug safety and related methodologies.
• Ability to synthesize complex data and drive evidence-based safety programs.
• Experience in global, multi-disciplinary drug development with external partners.

Responsibilities

• Own end-to-end safety strategy across the Therapeutic Area with integrated decision-making.
• Lead Safety Board governance and executive discussions on go/no-go, labeling, and development strategy.
• Build and mentor a high-performing safety organization and advance analytics/AI-enabled capability.
• Interface with regulatory authorities and lead risk assessment for global submissions.
• Drive safety due diligence for business development and strategic partnerships.

Skills

Regulatory knowledge

Leadership

People management

PV strategy

Data synthesis

Strategic thinking

Communication

Global collaboration

Pharmacovigilance

Education

Medical Degree (MD/DO)

Advanced degree (PhD/MPH)

Job description

Takeda in Boston, MA seeks a Principal Safety leader to own enterprise-wide safety strategy for GI2 development and marketed products. You will influence go/no-go decisions, labeling, and development strategy, shaping regulatory outcomes and building a forward-looking safety organization.

Leading Safety Board discussions and external regulatory interactions, you will drive data-driven risk management, mentor PV scientists, and advance capabilities including analytics and AI-driven safety