Senior Scientist II - Non-clinical Safety
About the role
The Senior Scientist II will be responsible for strategy implementation and operations for conducting and summarizing non-clinical safety studies internally and externally on new drug substances. Designs toxicology, safety pharmacology and toxico-pathological investigations in line with relevant GxP requirements in non-clinical development programs. Studies the safety related effects of biological and chemical entities in in vitro systems and animals and conducts non-clinical safety investigations on experimental drugs and other substances relevant to drug development. Develops and improves in vitro and in vivo methods for non-clinical safety evaluation, analyzes and prepares reporting of findings, performs advisory functions and communicates evaluations and implications of non-clinical safety findings. Prepares and reviews non-clinical safety sections of regulatory submissions as relevant.
Essential Functions
- Lead Non-Clinical Safety Studies
- Design and oversee toxicology studies in line with GxP requirements (including clinical pharmacology, safety pharmacology, and histopathological endpoints)
- Conduct and summarize non-clinical safety studies
- Ensure the application of best practices and innovative approaches to improve study outcomes
Qualifications
- BS/BA with 12+ years of relevant experience; or master’s degree with 10+ years of relevant experience; or PhD with 6+ years’ of relevant experience required
- Demonstrates subject matter expertise in non-clinical safety evaluation
- Applies solid knowledge and skills relevant for cross-functional understanding within the business
- Uses best practices and knowledge of internal or external business issues to improve products or services
- Works independently with minimal guidance, handling specialist tasks of high complexity
- Analyzes and prepares reporting of findings, performing advisory functions and communicating evaluations
- Prepares and reviews non-clinical safety sections of regulatory submissions
- Designs and improves in vitro and in vivo methods for non-clinical safety evaluation