Sr. Medical Director, Gastrointestinal and Inflammation (Remote)

Role Summary

Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI²) at Takeda. Oversees medical safety activities and processes for assigned products, ensuring continuous assessment of safety profiles and benefit-risk of investigational and marketed compounds. Provides strategic, patient-focused leadership for medical safety and supports asset strategies and medical/scientific innovation.

Responsibilities

• May directly manage a group of Global Safety Leaders (GSL) and PV Scientists responsible for the medical safety profile of assigned products.
• Interact with and influence colleagues from other functions to develop and implement safety and benefit-risk assessment strategies.
• Oversee signal detection and risk management activities and ensure development plans include comprehensive safety assessment plans.
• Support compounds/initiatives outside primary therapeutic areas as directed.
• Lead PSPV Safety Team (GST) and Safety Management Team (SMT) for assigned GI compounds and products.
• Represent the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders.
• Manage cross-functional assessment of benefit-risk and communication of safety information.
• Lead interpretation of safety data and communicate implications for go/no-go decisions or modifications to development plans or study design.
• Mentor GSLs and PV Scientists on development and marketed drugs, safety monitoring and risk management.
• Support cross-functional evaluations for presentations to the Takeda Safety Board and similar forums.
• Manage reactive responses to emerging safety signals.
• Possibly perform medical safety evaluations for new business development opportunities.
• Ensure high-quality analyses of safety information for regulatory submissions and interactions with authorities.
• Assist in assessing regulatory intelligence implications and developing process strategies.
• Oversee risk management plans for development and marketed drugs.
• Ensure GSLs proactively identify safety concerns and develop contingency strategies.
• Maintain professional knowledge via continuing medical education and foster continual learning.

Qualifications

• Medical Degree (MD) required or internationally recognized equivalent, ideally with Advanced Degree.
• 8+ years of experience in Pharmacovigilance, Clinical Research, or Clinical Development within pharma/academia/CRO, including global PV experience.
• Minimum of 3 years of people management experience.
• Knowledge of regulatory agency requirements regarding drug safety and general drug safety methodologies.
• Ability to synthesize complex data and implement programs/procedures to achieve objectives.
• Experience in a multi-disciplinary, international drug development environment across therapeutic areas.
• Ability to anticipate changes in the medical safety landscape and inform strategy.
• Demonstrated leadership in people management, team building, and mentoring.
• Ability to work productively in a fast-moving environment.
• Strong analytical and judgment capabilities and excellent time management.
• Computer literacy with safety database acumen; self-directed and autonomous.
• Strong facilitation and presentation skills; excellent spoken and written communication.
• Proven ability to work globally and cross-functionally with strong interpersonal skills.

Skills

• Safety data interpretation and risk assessment
• Strategic leadership in pharmacovigilance
• Cross-functional collaboration
• Regulatory submission support
• Mentoring and team development
• Communication and presentation

Education

• Medical Degree (MD) required or internationally recognized equivalent; advanced degree preferred.