Purpose:

Group Medical Director manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and PST leads (and could support one large product as the PST Lead) and ensuring safety of late stage and post marketing Solid Tumor-oncology portfolio (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on Solid Tumor-oncology late stage group of assets with similar mechanism of action (overarching across assets)

Responsibilities:

• Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc)
• Asset strategy lead safety representatives for larger programs (late stage)
• Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery
• Works closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA
• Leads and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA
• Proactively seeks to understand “WHY” a safety concern or risk emerge and “How” to mitigate it
• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
• Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
• Effectively write, review and provide input on technical documents independently
• Oversight and responsibility for leading the strategy for periodic reports (PSUR’s, PADER’s etc.)
• Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
• Responsible for implementing risk management strategies for assigned products
• Proactively engaging, inspiring, coaching and mentoring team and colleagues
• Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development.
• Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval related activities.