Principal Research Scientist II, Toxicology
The Principal Research Scientist II, Toxicology is responsible for the conduct of toxicology and safety pharmacology studies, as well as preclinical evaluations of compounds under development at AbbVie. This role ensures the establishment of optimal toxicology development plans for new chemical, bio-therapeutics or product opportunities, and the implementation of these plans, based on project priorities to ensure orderly and timely progression within set target dates, through in-house or contract research organizations in full compliance and adherence with FDA, USDA and GLP regulations.
This position has responsibility for ensuring high quality and integrity of the data as well as proper interpretation and valid conclusions in support of product safety and dose selection for initiating clinical investigations or regulatory submissions. Serves as departmental representative in project teams, and coordinates activities with cross-functional departments within the company. The Principal Research Scientist II authors toxicology and safety pharmacology sections and contributes to efficacy and safety sections of INDs, NDAs, BLAs, IBs for worldwide regulatory submissions, and coordinates and reviews technical responses to regulatory questions.
- Develops and achieves discipline strategy in alignment with functional goals and key scientific objectives. Collaborates with experts within function to integrate scientific objectives into activities associated with development of new/improved products or technology.
- Advances scientific expertise within function. Proactively demonstrates leadership by advises and shares knowledge and expert opinions with subordinates, peers, and senior management. Mentors and trains functional colleagues and assess current and emerging business challenges enabling functional goal achievement.
- Ensures quality and effectiveness of key results of major project plans within function through sound design, early risk assessments, and implementation of fallback strategies.
- Sources and identifies emerging scientific trends from multiple internal and external sources and assess relevance. Integrates trends into functional short-term objectives. Advances cross-discipline technology and direction through generation of data.
- Applies imagination and innovation by creating, inventing, and implementing new or better approaches, alternatives and breakthrough ideas that are valued by customers within the function.
- Presents scientific concepts and results for functional scientific and non-scientific leaders as well as potential and existing partners. Maximizes impact and value of expertise.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.