Group Medical Director

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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 hematology-oncology portfolio (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on hematology-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 and chemistry 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 regula