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, supports asset strategies, and strengthens medical and scientific innovation.

Responsibilities

• May directly manage a group of Global Safety Leaders (GSLs) and PV Scientists responsible for overseeing the medical safety profile for assigned products.
• Influence colleagues from other functions to ensure comprehensive safety and benefit-risk assessment strategies for products.
• Oversee signal detection and risk management activities and ensure development plans include comprehensive safety assessment plans.
• Flexible to support compounds/initiatives outside the 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 in development and marketed drugs, safety monitoring and risk management analysis.
• Support cross-functional evaluations for presentations to the Takeda Safety Board and similar forums.
• Manage reactive response to emerging safety signals.
• May 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 strategies for processes and procedures.
• Oversee risk management plans for development and marketed drugs.
• Ensure GSLs proactively identify safety concerns and develop contingency strategies.
• Maintain professional knowledge through continuing medical education and foster continual learning.

Qualifications

• Medical Degree (MD) required or internationally recognized equivalent, ideally with an Advanced Degree.
• 8+ years in Pharmacovigilance, Clinical Research, or Clinical Development within pharma/academia/CRO, including global PV experience.
• Minimum 3 years of people management experience.
• Knowledge of regulatory requirements for drug safety and general drug safety methodologies.
• Ability to synthesize complex data and implement programs/procedures to achieve corporate objectives.
• Experience in a multi-disciplinary, international drug development environment across therapeutic areas.
• Strong leadership, team-building, and mentoring skills; ability to manage in a fast-moving environment.
• Excellent analytical, judgment, time management, and communication skills (oral and presentation).
• Computer literacy with safety database experience; self-motivated and autonomous; able to facilitate and lead meetings.
• Proven ability to work globally and cross-functionally with strong interpersonal skills.