Group Medical Director
4 Days Old
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.
Purpose : 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.
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 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 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 interpretations to cross-functional teams
Effectively write, review, and provide input on technical documents independently
Oversight and responsibility for leading the strategy for periodic reports (PSURs, PADERs, 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
Qualifications :
MD/DO with 2+ years of residency with patient management experience
Master's in Public Health or PhD preferred, 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 a 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
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.
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- Location:
- North Chicago, IL, United States
- Job Type:
- FullTime
- Category:
- Bio & Pharmacology & Health