Medical Director, Gastrointestinal & Inflammation (Remote)

Role Summary

Medical Director, Gastrointestinal & Inflammation (Remote) at Takeda. Responsible for global safety leadership, risk management, and medical safety oversight for assigned products, with collaboration across cross-functional teams and regulatory authorities.

Responsibilities

• Serves as Global Safety Lead (GSL) and the company-wide patient safety expert for assigned products, accountable for safety strategy and major safety deliverables.
• Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned 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 and communicates safety information for assigned compounds and products.

Accountabilities

• Analyze and interpret safety data from non-clinical, clinical, post-marketing, and literature sources.
• Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
• Develop strategy and lead responses to safety-related inquiries from regulatory agencies and ethics committees.
• Ensure communication of safety information that may impact benefit-risk to senior management.
• Provide medical safety expertise and contribute to critical documents (protocols, amendments, ICFs, IBs, IMPDs, clinical reports, SAEs, regulatory submissions) in collaboration with cross-functional colleagues.
• Provide patient safety input to the development program and represent GPSE on governance bodies for protocols and other study-related documents.
• Manage benefit-risk documents (e.g., RMPs) for assigned products.
• Collaborate with Clinical Development, Regulatory, QA, Medical Affairs, Marketing, Manufacturing, and Legal to address safety issues.
• Interact with Regulatory Authorities as part of cross-functional teams for submissions and inquiries (MAAs, NDAs, BLAs).
• Maintain up-to-date safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents.
• Demonstrate knowledge of local and global health authority requirements.
• Support GPSE in maintaining a highly effective global safety organization in compliance with worldwide regulations.
• Train and mentor Pharmacovigilance Physicians and Specialists.
• Maintain professional knowledge through continuing medical education and foster continual learning.

Qualifications

• M.D. or D.O. or internationally recognized equivalent; board certification and licensure preferred.
• At least 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance (investigational and marketed products).
• At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management.
• Knowledge of national and international PV and regulatory guidelines.

Travel Requirements

Local and international travel across Takeda sites may be required.