Medical Director, Gastrointestinal & Inflammation (Remote)
Takeda
9 hours ago
Remote
United States
$237,200 - $372,790 USD yearly
Medical Affairs
POSITION OBJECTIVES (Principal Responsibilities)
- Serve as Global Safety Lead (GSL) and company-wide patient safety expert for assigned pharmaceutical/biological/drug-device combined products; accountable for safety strategy and major safety deliverables.
- Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.
- Represent the cross-functional program team as product safety profile and risk mitigation expert for internal (e.g., Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders.
- Manage cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds/products.
POSITION ACCOUNTABILITIES
- Analyze and interpret safety data from non-clinical, clinical, post-marketing, and scientific literature.
- Conduct signal detection, monitoring, evaluation, interpretation, and management.
- Develop strategy and 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 (e.g., 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 governance bodies for study protocols, statistical analysis plans, and related documents.
- Manage benefit-risk profile; author/update benefit-risk documents (e.g., RMPs).
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal on safety issues.
- Interact with Regulatory Authorities to submit and defend regulatory inquiries (e.g., MAAs, NDAs, BLAs).
- Maintain up-to-date safety information in Company Core Data Sheet and Investigator Brochure, plus other labeling documents.
- Demonstrate knowledge of local and global health authority requirements; support compliance of global safety organization.
- Train and mentor Pharmacovigilance Physicians and Specialists.
- Maintain professional knowledge via continuing medical education.
EDUCATION / QUALIFICATIONS
- M.D. or D.O. (or internationally recognized equivalent) with post-graduate clinical patient care experience; board certification and licensure preferred.
- 5+ years in pharmaceutical industry within Drug Safety/Pharmacovigilance (investigational and marketed products).
- 3+ years in aggregate reporting, safety surveillance, signal management and/or risk management.
- Knowledge of national and international PV and regulatory guidelines.
TRAVEL
- Local and international travel across Takeda sites may be required.
APPLICATION INSTRUCTIONS
- No Phone Calls or Recruiters Please.
- Serve as Global Safety Lead (GSL) and company-wide patient safety expert for assigned pharmaceutical/biological/drug-device combined products; accountable for safety strategy and major safety deliverables.
- Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.
- Represent the cross-functional program team as product safety profile and risk mitigation expert for internal (e.g., Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders.
- Manage cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds/products.
POSITION ACCOUNTABILITIES
- Analyze and interpret safety data from non-clinical, clinical, post-marketing, and scientific literature.
- Conduct signal detection, monitoring, evaluation, interpretation, and management.
- Develop strategy and 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 (e.g., 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 governance bodies for study protocols, statistical analysis plans, and related documents.
- Manage benefit-risk profile; author/update benefit-risk documents (e.g., RMPs).
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal on safety issues.
- Interact with Regulatory Authorities to submit and defend regulatory inquiries (e.g., MAAs, NDAs, BLAs).
- Maintain up-to-date safety information in Company Core Data Sheet and Investigator Brochure, plus other labeling documents.
- Demonstrate knowledge of local and global health authority requirements; support compliance of global safety organization.
- Train and mentor Pharmacovigilance Physicians and Specialists.
- Maintain professional knowledge via continuing medical education.
EDUCATION / QUALIFICATIONS
- M.D. or D.O. (or internationally recognized equivalent) with post-graduate clinical patient care experience; board certification and licensure preferred.
- 5+ years in pharmaceutical industry within Drug Safety/Pharmacovigilance (investigational and marketed products).
- 3+ years in aggregate reporting, safety surveillance, signal management and/or risk management.
- Knowledge of national and international PV and regulatory guidelines.
TRAVEL
- Local and international travel across Takeda sites may be required.
APPLICATION INSTRUCTIONS
- No Phone Calls or Recruiters Please.