Sr. Medical Director, Gastrointestinal and Inflammation (Remote)

Role Summary

Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI²). Oversees medical safety activities and processes for assigned products, ensuring continuous assessment of safety profiles and benefit-risk of investigational and marketed compounds. Provides strategic, patient-focused leadership for medical safety, supports asset strategies, and strengthens medical and scientific innovation.

Responsibilities

• May directly manage a group of GSLs and PV Scientists responsible for overseeing the medical safety profile for assigned products.
• Interact with and influence colleagues from other functions to ensure the successful development, design and implementation of comprehensive safety and benefit-risk assessment strategies for products.
• Oversee signal detection and risk management activities for assigned products and ensure 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.
• Lead PSPV Safety Team (GST) and Safety Management Team (SMT) for assigned GI compounds and products.
• Represent the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders.
• Manage cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Lead the interpretation of safety data from internal and external sources, assess scientific and medical implications, and communicate impact on decisions, development plans, study design, timelines, or labeling, ensuring patient safety.
• Mentor GSLs and PV Scientists regarding development and marketed drugs, safety monitoring and risk management analysis.
• Support cross-functional evaluations for presentations to the Takeda Safety Board and similar forums; prepare and present materials as a key player.
• Manage reactive response to emerging safety signals.
• May perform medical safety evaluation of projects for new business development opportunities (e.g., due diligence).
• Ensure high quality analyses of safety information in support of regulatory submissions and interactions with regulatory authorities.
• Assist in assessing implications of regulatory intelligence and developing strategies for adapting processes and procedures.
• Oversee risk management plans for compounds in development and marketed drugs.
• Ensure GSLs proactively identify safety concerns and develop contingency strategies.
• Maintain professional knowledge and accreditation through continuing medical education and foster continual learning.

Qualifications

• Medical Degree (MD) required or internationally recognized equivalent, ideally with an Advanced Degree.
• 8+ years of experience in Pharmacovigilance, Clinical Research, or Clinical Development within the pharmaceutical industry, academia, and/or CRO, including global pharmacovigilance experience.
• Minimum of 3 years of people management experience.
• Knowledge of regulatory agency requirements regarding drug safety and general drug safety methodologies.
• Ability to synthesize complex data and implement programs/processes to achieve corporate objectives.
• Experience in a multi-disciplinary drug development environment with international exposure and diverse therapeutic areas.
• Ability to anticipate changes in the medical safety landscape and understand patient impact.
• Demonstrated leadership in people management, team building, and mentoring.
• Ability to work in a fast-moving, high-pressure environment.
• Strong analytical and judgment skills; effective written and oral communication.
• Strong time management and prioritization skills; computer literacy, including safety databases.
• Self-directed with initiative and autonomy; capable of leading meetings in various formats.
• Excellent communication and presentation skills; demonstrated ability to work globally and cross-functionally with strong interpersonal skills.

Skills

• Pharmacovigilance leadership
• Safety signal detection and risk management
• Cross-functional collaboration
• Safety data interpretation and regulatory communication
• Mentoring and people management
• Strategic safety planning and development
• Regulatory submissions and interactions

Education

• MD required or internationally recognized equivalent; advanced degree preferred.

Additional Requirements

• Remote work eligibility; location Massachusetts (Virtual)