Apply📍 United States of America
🧭 Full-Time
💸 256200.0 - 402600.0 USD per year
🔍 Pharmaceutical
🏢 Company: external
- Medical Degree (MD) required or internationally recognized equivalent ideally combined with Advanced Degree.
- 8 years+ of experience gained 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.
- Minimum of 3 years of experience in people management.
- Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug safety methodologies.
- Ability to comprehend and synthesize complex data and should have experience in the identification, analysis, and implementation of programs and procedures required to achieve corporate objectives.
- Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.
- Identifies opportunities and anticipates changes in the medical safety. landscape through an understanding and ongoing assessment of the environment affecting the Patient.
- Must have demonstrable experience in people management at a leadership level and well-developed skills in team building, motivating, empowering, and developing people.
- Work productively in a fast-moving and pressured environment.
- Good analytical/judgment capabilities to understand, analyze/synthesize and communicate successfully and concisely.
- Well-developed time management skillset to assist in prioritization of multiple issues
- Computer literate, including safety database acumen
- Self-resourced, with the confidence to take the initiative and act autonomously
- Both facilitate and efficiently lead meetings, both in person and in other media
- Excellent communication skillset, orally and presentational
- Proven ability to work globally and cross-functionally, with strong interpersonal skills /appropriately assertive /team-minded and mentoring.
- 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.
- 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 (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 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. The Senior Medical Director will be a key player in the preparation and presentation of materials 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.
LeadershipProject ManagementSQLData AnalysisPeople ManagementCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationProblem SolvingMentoringOrganizational skillsTime ManagementWritten communicationComplianceAdaptabilityTeamworkRisk ManagementStrategic thinkingFinancial analysisBudget management
Posted 5 days ago
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