Sr. Medical Director, Gastrointestinal and Inflammation (Remote)
Takeda
12 hours ago
Remote
United States
$257,600 - $404,800 USD yearly
Medical Affairs
Responsibilities:
- 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; strengthen medical and scientific innovation.
- Ensure timely escalation of safety issues to the Takeda Safety Board Chair.
- Define and implement a vision for Patient Safety; enhance medical safety capabilities; serve on company-wide committees and governance.
- May manage/oversee physicians and HCPs serving as Global Safety Leaders (GSL) and PV Scientists for compounds in both clinical development and marketed settings.
- Lead PSPV Safety Team (GST) and Safety Management Team (SMT) for assigned GI compounds/products.
- Oversee signal detection and risk management; ensure development plans include comprehensive safety assessment plans.
- Represent cross-functional program teams as 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” decisions or modification of development plans/study design, including potential effects on timelines/labeling.
- Mentor GSLs and PV Scientists; support safety-related cross-functional evaluations for Safety Board presentations.
- 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 to support regulatory submissions and interactions with regulators worldwide.
- Assist GI Therapeutic Area Head with regulatory intelligence implications and process adaptation.
- Oversee risk management plans; ensure proactive identification of safety concerns and contingency strategies.
Minimum Requirements/Qualifications:
- MD required (or internationally recognized equivalent), ideally with an advanced degree.
- 8+ years’ experience in pharmacovigilance, clinical research, or clinical development (pharma industry/academia/CRO), including significant experience in a global pharmacovigilance organization.
- 3+ years of people management experience.
- Demonstrated knowledge of regulatory agency drug-safety requirements and drug safety methodologies.
- Ability to comprehend/synthesize complex data; identify, analyze, and implement programs/procedures to meet corporate objectives.
- Experience in multi-disciplinary, international drug development across therapeutic areas.
- Leadership-level people management skills (team building, motivating, empowering, developing).
- Work effectively in a fast-moving, pressured environment.
- Strong analytical/judgment, time management, and communication (oral/presentational).
- Computer literate, including safety database experience.
- Ability to act autonomously and lead/facilitate meetings in-person and remotely.
Benefits:
- U.S. base salary range: $257,600.00–$404,800.00.
- Eligible for short-term/long-term incentives (U.S. based).
- Eligible for medical, dental, vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits.
- Up to 80 hours sick time per calendar year; new hires eligible to accrue up to 120 hours paid vacation.
Application instructions:
- By clicking the “Apply” button, you begin the employment application process and consent to processing of your information per Takeda’s Privacy Notice and Terms of Use.
- 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; strengthen medical and scientific innovation.
- Ensure timely escalation of safety issues to the Takeda Safety Board Chair.
- Define and implement a vision for Patient Safety; enhance medical safety capabilities; serve on company-wide committees and governance.
- May manage/oversee physicians and HCPs serving as Global Safety Leaders (GSL) and PV Scientists for compounds in both clinical development and marketed settings.
- Lead PSPV Safety Team (GST) and Safety Management Team (SMT) for assigned GI compounds/products.
- Oversee signal detection and risk management; ensure development plans include comprehensive safety assessment plans.
- Represent cross-functional program teams as 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” decisions or modification of development plans/study design, including potential effects on timelines/labeling.
- Mentor GSLs and PV Scientists; support safety-related cross-functional evaluations for Safety Board presentations.
- 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 to support regulatory submissions and interactions with regulators worldwide.
- Assist GI Therapeutic Area Head with regulatory intelligence implications and process adaptation.
- Oversee risk management plans; ensure proactive identification of safety concerns and contingency strategies.
Minimum Requirements/Qualifications:
- MD required (or internationally recognized equivalent), ideally with an advanced degree.
- 8+ years’ experience in pharmacovigilance, clinical research, or clinical development (pharma industry/academia/CRO), including significant experience in a global pharmacovigilance organization.
- 3+ years of people management experience.
- Demonstrated knowledge of regulatory agency drug-safety requirements and drug safety methodologies.
- Ability to comprehend/synthesize complex data; identify, analyze, and implement programs/procedures to meet corporate objectives.
- Experience in multi-disciplinary, international drug development across therapeutic areas.
- Leadership-level people management skills (team building, motivating, empowering, developing).
- Work effectively in a fast-moving, pressured environment.
- Strong analytical/judgment, time management, and communication (oral/presentational).
- Computer literate, including safety database experience.
- Ability to act autonomously and lead/facilitate meetings in-person and remotely.
Benefits:
- U.S. base salary range: $257,600.00–$404,800.00.
- Eligible for short-term/long-term incentives (U.S. based).
- Eligible for medical, dental, vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits.
- Up to 80 hours sick time per calendar year; new hires eligible to accrue up to 120 hours paid vacation.
Application instructions:
- By clicking the “Apply” button, you begin the employment application process and consent to processing of your information per Takeda’s Privacy Notice and Terms of Use.