Group Medical Director, Patient Safety

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. The Group Medical Director manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, leading Product Safety Teams (PST) and ensuring safety of late-stage and post-marketing Solid Tumor-oncology portfolio. Purpose: Leading Product Safety Teams (PST) and PST leads, ensuring safety of late-stage and post-marketing Solid Tumor-oncology portfolio, and interpreting regulations related to pharmacovigilance. 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 guides 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 emerges 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 analyses 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 Qualifications: MD/DO with 2+ years of residency with patient management experience Master Public Health or PhD is preferred in addition to MD/DO, not required 8-10 years of Pharmacovigilance/Clinical Development experience in the pharmaceutical industry Effectively analyze and guide analysis of clinical data and epidemiological information Effectively present recommendations/opinions in group environment both internally and externally Write, review, and provide input on technical documents Work collaboratively and lead cross-functional teams Ability to lead cross-functional teams in a collaborative environment Fluency, both written and oral, in English Evaluate and make independent decisions. Ability to work effectively in situations of uncertainty and complexity, ability to multitask Experiences/Leadership traits: Ability to work collaboratively with colleagues with different areas of expertise (e.g., epidemiology, statistics) Ability to make independent decisions Ability to influence cross-functional stakeholders - internal and across industry, and regulatory authorities A clear understanding of PV and clinical development and monitoring clinical trial and post-marketing safety Ability to respect other opinions and be inclusive of different points of view and be open to the ideas of others AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.

#J-18808-Ljbffr