Sr. Medical Director, Gastrointestinal and Inflammation (Remote)
Takeda
8 hours ago
Remote
United States
$257,600 - $404,800 USD yearly
Medical Affairs
How you will contribute:
- Oversee medical safety activities and processes for assigned products; ensure continuous assessment of safety profiles and benefit-risk for investigational and marketed compounds.
- Provide strategic, patient-focused leadership for medical safety; support asset strategies and strengthen medical/scientific innovation.
- Ensure timely escalation of safety issues to the Takeda Safety Board Chair; define and implement a vision for Patient Safety; participate in company-wide Committees and Governance.
- May manage/oversee physicians and HCPs serving as Global Safety Leaders (GSL) and PV Scientists.
- May directly manage a group of GSLs and PV Scientists.
- Coordinate with cross-functional colleagues to develop and implement safety and benefit-risk assessment strategies.
- Oversee signal detection and risk management; ensure development plans include comprehensive safety assessment plans.
- Lead PSPV Safety Team (GST) and Safety Management Team (SMT) for assigned GI compounds/products.
- Represent cross-functional program team as a product safety/risk mitigation expert for internal and external stakeholders.
- Manage cross-functional benefit-risk assessment and communication of safety information.
- Interpret safety data from internal/external sources; assess scientific/medical implications; communicate impact on “go/no go,” development plan/study design, including timeline or labeling changes.
- Mentor GSLs and PV Scientists; prepare materials for Takeda Safety Board and similar forums.
- Manage reactive response to emerging safety signals.
- May perform medical safety evaluation for new business development (e.g., due diligence).
- Ensure high-quality safety analyses supporting regulatory safety updates, IND/NDA submissions, and interactions with global regulatory authorities.
- Assist TA Head in assessing emerging regulatory intelligence and adapting processes/procedures.
- Oversee risk management plans; ensure proactive identification of safety concerns and contingency strategies.
- Maintain professional knowledge via continuing medical education.
Minimum Requirements/Qualifications:
- MD (or internationally recognized equivalent), ideally with an advanced degree.
- 8+ years in pharmacovigilance, clinical research, or clinical development (industry/academia/CRO), including significant experience in global pharmacovigilance.
- 3+ years of people management experience.
- Knowledge of regulatory agency drug safety requirements and drug safety methodologies.
- Ability to comprehend/synthesize complex data; experience implementing programs/procedures to meet corporate objectives.
- Experience in multi-disciplinary, international drug development across therapeutic areas.
- Ability to anticipate changes in the patient safety landscape.
- Leadership people management skills (team building, motivating, empowering, developing).
- Ability to work productively in fast-paced, high-pressure environments.
- Strong analytical/judgment and concise communication skills; strong time management.
- Computer literate, including safety database experience.
- Self-directed and able to act autonomously.
- Ability to facilitate and lead meetings across media.
- Proven ability to work globally and cross-functionally with strong interpersonal skills.
Benefits (if applicable per description):
- Eligible for medical/dental/vision insurance, 401(k) with match, disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year and up to 120 hours paid vacation for new hires; may be eligible for short- and long-term incentives.
Application instructions:
- Not specified beyond the initial “Apply” button notice.
- Oversee medical safety activities and processes for assigned products; ensure continuous assessment of safety profiles and benefit-risk for investigational and marketed compounds.
- Provide strategic, patient-focused leadership for medical safety; support asset strategies and strengthen medical/scientific innovation.
- Ensure timely escalation of safety issues to the Takeda Safety Board Chair; define and implement a vision for Patient Safety; participate in company-wide Committees and Governance.
- May manage/oversee physicians and HCPs serving as Global Safety Leaders (GSL) and PV Scientists.
- May directly manage a group of GSLs and PV Scientists.
- Coordinate with cross-functional colleagues to develop and implement safety and benefit-risk assessment strategies.
- Oversee signal detection and risk management; ensure development plans include comprehensive safety assessment plans.
- Lead PSPV Safety Team (GST) and Safety Management Team (SMT) for assigned GI compounds/products.
- Represent cross-functional program team as a product safety/risk mitigation expert for internal and external stakeholders.
- Manage cross-functional benefit-risk assessment and communication of safety information.
- Interpret safety data from internal/external sources; assess scientific/medical implications; communicate impact on “go/no go,” development plan/study design, including timeline or labeling changes.
- Mentor GSLs and PV Scientists; prepare materials for Takeda Safety Board and similar forums.
- Manage reactive response to emerging safety signals.
- May perform medical safety evaluation for new business development (e.g., due diligence).
- Ensure high-quality safety analyses supporting regulatory safety updates, IND/NDA submissions, and interactions with global regulatory authorities.
- Assist TA Head in assessing emerging regulatory intelligence and adapting processes/procedures.
- Oversee risk management plans; ensure proactive identification of safety concerns and contingency strategies.
- Maintain professional knowledge via continuing medical education.
Minimum Requirements/Qualifications:
- MD (or internationally recognized equivalent), ideally with an advanced degree.
- 8+ years in pharmacovigilance, clinical research, or clinical development (industry/academia/CRO), including significant experience in global pharmacovigilance.
- 3+ years of people management experience.
- Knowledge of regulatory agency drug safety requirements and drug safety methodologies.
- Ability to comprehend/synthesize complex data; experience implementing programs/procedures to meet corporate objectives.
- Experience in multi-disciplinary, international drug development across therapeutic areas.
- Ability to anticipate changes in the patient safety landscape.
- Leadership people management skills (team building, motivating, empowering, developing).
- Ability to work productively in fast-paced, high-pressure environments.
- Strong analytical/judgment and concise communication skills; strong time management.
- Computer literate, including safety database experience.
- Self-directed and able to act autonomously.
- Ability to facilitate and lead meetings across media.
- Proven ability to work globally and cross-functionally with strong interpersonal skills.
Benefits (if applicable per description):
- Eligible for medical/dental/vision insurance, 401(k) with match, disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year and up to 120 hours paid vacation for new hires; may be eligible for short- and long-term incentives.
Application instructions:
- Not specified beyond the initial “Apply” button notice.