Sr. Medical Director, Gastrointestinal and Inflammation (Remote)

Role Summary

Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI²). 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 GSLs and PV Scientists responsible for overseeing the medical safety profile for assigned products.
• Influences colleagues from other functions to ensure the successful development, design and implementation of comprehensive safety and benefit-risk assessment strategies for products.
• Oversees signal detection and risk management activities for assigned products and ensures development plans include comprehensive safety assessment plans.
• Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs.
• Leads PSPV Safety Team (GST) and Safety Management Team (SMT) for assigned GI compounds and products.
• Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders.
• Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Leads interpretation of safety data and communicates implications for go/no go decisions or modification of development plans or study design.
• Mentors GSLs and PV Scientists with respect to safety monitoring and risk management for development and marketed drugs.
• Supports cross-functional evaluations for presentations to the Takeda Safety Board and similar forums.
• Manages reactive response to emerging safety signals.
• May perform medical safety evaluation of projects for new business development opportunities.
• Ensures high-quality analyses of safety information for regulatory submissions and interactions with regulatory authorities.
• Assists in assessing regulatory intelligence and developing strategies for adapting processes and procedures.
• Oversees risk management plans for compounds in development and marketed drugs.
• Ensures GSLs proactively identify safety concerns and develop contingency strategies.
• Maintains professional knowledge and accreditation through continuing medical education and fosters 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 the pharmaceutical industry and/or academia and/or CRO, including global pharmacovigilance experience.
• Minimum of 3 years of experience in people management.
• Demonstrated knowledge of regulatory agency requirements regarding drug safety and understanding of drug safety methodologies.
• Ability to synthesize complex data and implement programs and procedures to achieve corporate objectives.
• Experience in a multi-disciplinary, international drug development environment.
• Strong leadership and mentoring abilities, with effective team-building and communication skills.
• Ability to work productively in a fast-moving environment with strong analytical and time-management skills.
• Computer literacy including safety database proficiency.
• Self-driven, autonomous, and capable of leading meetings and cross-functional collaboration.
• Excellent oral, written, and presentation skills; proven ability to work globally and cross-functionally.

Skills

• Strategic leadership in medical safety and pharmacovigilance
• Safety signal detection and risk management
• Cross-functional collaboration and stakeholder management
• Data synthesis and interpretation for development decisions
• Mentoring and people leadership
• Regulatory knowledge and communication
• Safety data analysis and regulatory submissions
• Effective communication and presentation

Education

• MD or equivalent; advanced degree preferred

Additional Requirements

• Remote work eligibility as per policy; location: Massachusetts - Virtual