Job Description
The primary function is to assess the safety of experimental compounds by evaluating their effects across available nonclinical safety models. Act as a scientific subject matter expert for preclinical safety data for other AbbVie departments as a member of cross-functional project teams. Develop and conduct those portions of study protocols that deal with anatomic and clinical pathology including not only the collection and evaluation of data regarding gross, microscopic, ultra-structural, and clinical pathology but, lastly, the preparation of comprehensive reports correlating these data. Integrate data sourced from in vivo studies as well as in vitro models and in silico predictions to generate a comprehensive safety assessment for early drug development programs.
Responsibilities
- Provide scientific expertise to scientific staff of other departments as a member of cross-functional teams.
- In cooperation with the Toxicology Department, design, direct, and evaluate in vivo studies to determine the potential toxicity of experimental compounds in different species of animals. This includes advanced endpoints (molecular pathology, ultrastructure, imaging, -omics, etc)
- Integrates the anatomic pathology data, clinical pathology data and other study findings to generate a pathology report as a component of the Toxicology report.
- Partner with toxicologists, pathologists and other functions to develop optimal strategies to address specific toxicology issues as well as select and advance Development compounds.
- Ability to function in multidisciplinary teams to address regulatory queries.
- Serves and/or leads issue resolution teams and participates in due diligence teams.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.