Sr. Medical Director, Gastrointestinal and Inflammation (Remote)

Role Summary

Sr. Medical Director, Gastrointestinal and Inflammation (Remote) 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 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.
• Interact with and influence colleagues from other functions to develop and implement comprehensive 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, ensuring patient safety.
• Mentor GSLs and PV Scientists regarding 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 and developing strategies to adapt processes.
• Oversee risk management plans for development and marketed drugs and ensure proactive identification of safety concerns with contingency plans.
• 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 of experience in Pharmacovigilance, Clinical Research, or Clinical Development in the pharmaceutical industry and/or academia/CRO with global PV experience.
• Minimum 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 to achieve corporate objectives.
• Experience in a multi-disciplinary, international drug development environment across therapeutic areas.
• Strong opportunities identification and ongoing assessment of the medical safety landscape.
• Demonstrated leadership in people management, team building, motivation, and development.
• Ability to work productively in a fast-moving environment with strong analytical and time-management skills.
• Computer literacy including safety database proficiency.
• Self-directed, autonomous, capable of leading meetings and cross-functional collaboration.
• Excellent spoken and written communication skills; able to present effectively.
• Proven ability to work globally and cross-functionally with strong interpersonal skills and mentoring abilities.

Skills

• Pharmacovigilance leadership
• Safety signal detection and risk management
• Cross-functional collaboration
• Regulatory submissions and interactions
• Strategic safety planning
• Mentoring and team leadership
• Data interpretation and decision making

Education

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