Medical Director, Gastrointestinal & Inflammation (Remote)

Role Summary

Medical Director, Gastrointestinal & Inflammation (Remote) leads global safety activities for assigned pharmaceutical/biological/drug-device products, serving as the safety strategy owner and medical safety expert across the product lifecycle.

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 profile and communication of safety information for assigned compounds and products.

Responsibilities (cont.)

• Analyze and interpret safety data from non-clinical, clinical, post-marketing, and scientific literature.
• Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
• Develop strategy and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
• Ensure communication of safety information that may impact the benefit-risk profile to senior management.
• Provide medical safety expertise, interpretation, review, and authorship of sections for critical documents in collaboration with cross-functional colleagues.
• Provide patient safety input to the clinical development program and represent GPSE on governance bodies for study protocols and related documents.
• Manage benefit-risk documents (e.g., RMPs) for assigned compounds and products.
• Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Interact with Regulatory Authorities to submit and defend regulatory inquiries, MAAs, NDAs, and BLAs.
• Ensure up-to-date safety information in Core Data Sheet, Investigator Brochure, and 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 a learning community.

Qualifications

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

Travel Requirements

• Local and international travel across Takeda sites may be required.