Medical Director, Gastrointestinal & Inflammation (Remote)
Takeda
12 hours ago
Remote
United States
$237,200 - $372,790 USD yearly
Medical Affairs
POSITION OBJECTIVES (Principal responsibilities):
- 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 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.
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 for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
- Ensure communication of safety information impacting benefit-risk 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) with cross-functional colleagues.
- Provide patient safety input to clinical development; represent GPSE on governance bodies for protocols, statistical analysis plans, and related documents.
- Manage benefit-risk profile and author/update benefit-risk documents (e.g., RMPs).
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
- Interact with Regulatory Authorities to submit/defend regulatory inquiries and applications (MAAs, NDAs, BLAs).
- Ensure up-to-date safety information in Company Core Data Sheet, Investigator Brochure, and labeling.
- Demonstrate knowledge of local and global health authority requirements.
- Support GPSE global safety organization compliance; train and mentor Pharmacovigilance Physicians and Specialists.
- Maintain knowledge through continuing medical education.
EDUCATION / EXPERIENCE / SKILLS:
- M.D. or D.O. (or internationally recognized equivalent); post-graduate clinical experience and general medicine grounding; board certification and licensure preferred.
- At least 5 years in pharmaceutical industry within Drug Safety/Pharmacovigilance (investigational and marketed products).
- At least 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.
- 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 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.
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 for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
- Ensure communication of safety information impacting benefit-risk 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) with cross-functional colleagues.
- Provide patient safety input to clinical development; represent GPSE on governance bodies for protocols, statistical analysis plans, and related documents.
- Manage benefit-risk profile and author/update benefit-risk documents (e.g., RMPs).
- Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
- Interact with Regulatory Authorities to submit/defend regulatory inquiries and applications (MAAs, NDAs, BLAs).
- Ensure up-to-date safety information in Company Core Data Sheet, Investigator Brochure, and labeling.
- Demonstrate knowledge of local and global health authority requirements.
- Support GPSE global safety organization compliance; train and mentor Pharmacovigilance Physicians and Specialists.
- Maintain knowledge through continuing medical education.
EDUCATION / EXPERIENCE / SKILLS:
- M.D. or D.O. (or internationally recognized equivalent); post-graduate clinical experience and general medicine grounding; board certification and licensure preferred.
- At least 5 years in pharmaceutical industry within Drug Safety/Pharmacovigilance (investigational and marketed products).
- At least 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.