Associate Medical Director/Medical Director, Medical Safety Evaluation, Translational Medicine Immunology

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

Responsible for supporting Product Safety Leads (PSTLs)or serve as a PSTL under the supervision of the Group Medical Director to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation for one or more developmental products and during due diligence activities.  

Responsibilities:

•Understands and applies pharmacology, chemistry and non-clinical toxicology to effectively conduct safety assessments

• Contributes to the authorship of key safety documents (such as the Investigator’s Brochure or Development Safety Update Report) for early development assets

• Applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents

• Analyzes and interprets pre-clinical and clinical safety data and communicates the analyses and interpretations to cross-functional teams

• Conducts, summarizes and communicates safety assessments in due diligence activities for Immunology

Key Stakeholders:

PST Lead, Search and Evaluation Team, Project Management, Regulatory Affairs, Discovery, Clinical Operations

Qualifications

• MD / DO with 2+ years of residency with patient management experience (required)

• Expertise in translational science and/or early research in immune mechanisms of disease, as demonstrated, for example, through a peer**-**reviewed publication (preferred)

• Effectively analyzes pre-clinical and clinical data (required)

• Background in bench or clinical research is a plus

• Effectively writes technical documents with direction

• Works collaboratively in a team environment and is self-st