Senior Medical Director – Global Medical Safety – Oncology

Senior Medical Director – Global Medical Safety – Oncology

Requirements

• Medical Degree (M.D. or D.O.) or internationally recognized equivalent, with direct clinical patient care experience following post-graduate training and appropriate grounding and knowledge of general medicine.
• Minimum of 8 years experience in the pharmaceutical industry within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
• Minimum 3 years people management experience and/or proven leadership experience in managing a global, matrix team.
• Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills.

Responsibilities

• Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned oncology compounds and products.
• Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee) 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 oncology 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 Oncology 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.

Preferred Qualifications

• Board certification and licensure preferred.