Medical Director, Gastrointestinal & Inflammation (Remote)
Takeda
August 24, 2026
Remote
United States
$237,200 - $372,790 USD yearly
Medical Affairs
POSITION OBJECTIVES
Principal responsibilities include
- Serves as Global Safety Lead (GSL) and the company-wide patient safety expert for assigned pharmaceutical/biological/drug-device combined 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 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.
POSITION ACCOUNTABILITIES
- Analyze and interpret safety data from non-clinical, clinical, post-marketing, and scientific literature.
- Conduct signal detection, monitoring, evaluation, interpretation, and management.
- Lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
- Ensure communication of safety information impacting benefit-risk profile to senior management.
- Provide medical safety expertise and author/review critical documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, CTAs).
- Provide patient safety input to clinical development and represent GPSE on internal governance bodies.
- Manage benefit-risk profile and author/update benefit-risk documents (e.g., RMPs).
- Collaborate on safety issues 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.
- 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 global safety organization compliant with worldwide regulations.
- Train and mentor Pharmacovigilance Physicians and Specialists.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
- M.D. or D.O. (or equivalent) with direct clinical patient-care experience post-graduate; board certification and licensure preferred.
- 5+ years pharmaceutical industry experience in Drug Safety/Pharmacovigilance (investigational and marketed products).
- 3+ years experience in 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.
Principal responsibilities include
- Serves as Global Safety Lead (GSL) and the company-wide patient safety expert for assigned pharmaceutical/biological/drug-device combined 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 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.
POSITION ACCOUNTABILITIES
- Analyze and interpret safety data from non-clinical, clinical, post-marketing, and scientific literature.
- Conduct signal detection, monitoring, evaluation, interpretation, and management.
- Lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
- Ensure communication of safety information impacting benefit-risk profile to senior management.
- Provide medical safety expertise and author/review critical documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, CTAs).
- Provide patient safety input to clinical development and represent GPSE on internal governance bodies.
- Manage benefit-risk profile and author/update benefit-risk documents (e.g., RMPs).
- Collaborate on safety issues 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.
- 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 global safety organization compliant with worldwide regulations.
- Train and mentor Pharmacovigilance Physicians and Specialists.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
- M.D. or D.O. (or equivalent) with direct clinical patient-care experience post-graduate; board certification and licensure preferred.
- 5+ years pharmaceutical industry experience in Drug Safety/Pharmacovigilance (investigational and marketed products).
- 3+ years experience in 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.