Sr. Medical Director, Gastrointestinal and Inflammation (Remote)

Role Summary

Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI²). You will oversee medical safety activities and processes for assigned products, ensuring continuous assessment of safety profiles and benefit-risk of investigational and marketed compounds. You will provide strategic, patient-focused leadership for medical safety, support asset strategies, and strengthen medical and scientific innovation. Timely escalation of safety issues to the Takeda Safety Board Chair is required. You will define and implement a vision for Patient Safety, enhance medical safety capabilities, and be a core member of company-wide Committees and Governance.

Responsibilities

• May directly manage a group of GSLs and PV Scientists responsible for overseeing the medical safety profile for assigned products.
• Interacts with and influences colleagues from other functions to ensure the successful development, design and implementation of comprehensive safety and benefit-risk assessment strategies for products.
• Oversees signal detection and risk management activities for assigned products and ensures that development plans include comprehensive safety assessment plans.
• Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs.
• Leads PSPV Safety Team (GST) and Safety Management Team (SMT) for assigned GI 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 for assigned compounds and products.
• Leads the interpretation of safety data from internal and external sources, assessment of ensuing scientific and medical implications, and communication of the impact of same both in terms of “go/no go” decisions or modification of development plan or study design, including potential impact on timeline or product labeling, ensuring the primacy of patient safety.
• Mentors GSLs and PV Scientists with respect to compounds in development and marketed drugs, safety monitoring and risk management assessment and analysis.
• Supports cross-functional team evaluations in preparation for presentations to the Takeda Safety Board and similar forums.
• Manages the reactive response to emerging safety signals.
• May perform the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).
• Ensures high quality analyses of safety information, in support of safety update regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide.
• Assists the Global Medical Safety GI Therapeutic Area Head in assessing the implications of emerging regulatory intelligence and developing strategies for adapting processes and procedures.
• Oversees risk management plans for compounds in development and marketed drugs.
• Ensures that GSLs are proactively identifying safety concerns and developing contingency strategies that address these challenges.
• Maintains professional knowledge and accreditation by active participation in continuing medical education activities and fosters a community of continual learning.

Qualifications

• Required: Medical Degree (MD) or internationally recognized equivalent, ideally combined with an Advanced Degree.
• Required: 8+ years of experience in Pharmacovigilance, Clinical Research, or Clinical Development within the pharmaceutical industry and/or academia and/or CRO, including significant experience in operating in a global pharmacovigilance organization.
• Required: Minimum of 3 years of experience in people management.
• Required: Demonstrated knowledge of regulatory agency requirements regarding drug safety and understanding of general drug safety methodologies.
• Required: Ability to comprehend and synthesize complex data and experience in identifying, analyzing, and implementing programs and procedures to achieve corporate objectives.
• Required: Experience operating in a multi-disciplinary drug development environment with international exposure to multiple therapeutic areas.
• Required: Ability to identify opportunities and anticipate changes in the medical safety landscape through ongoing assessment of the Patient.
• Required: Demonstrated leadership in people management with strong team-building, mentoring, and development capabilities.
• Required: Ability to work productively in a fast-moving and high-pressure environment.
• Required: Strong analytical and judgment capabilities to understand, analyze, and communicate concisely.
• Required: Strong time management skills to prioritize multiple issues.
• Required: Computer literacy with safety database acumen.
• Required: Self-motivated, autonomous, and able to initiate actions without supervision.
• Required: Ability to facilitate and lead meetings effectively in person and virtually.
• Required: Excellent oral and presentation communication skills.
• Required: Proven ability to work globally and cross-functionally with strong interpersonal skills, assertiveness, team-mindedness, and mentoring.

Education

• Medical Degree (MD) or internationally recognized equivalent; advanced degree preferred.