- 5-6 years of experience of Toxicology, preclinical and CDISC-SEND in life science industry
- Demonstrate effective communication skills (written and oral)
- (For Sr. / Lead)Project planning and management.
Key Skills / Knowledge:
- Good understanding of various toxicological studies and their principles
- Capability of interpretation of results and analysis of key toxicity data, dose calculation/conversion
- Knowledge of OECD/FDA/EPA guidelines for preclinical toxicity studies
- Having understanding of toxicology studies (in silico, in vitro and in vivo)
- Knowledge of various toxicology/ pharmacology/ clinical/ regulatory databases like TOXNET, ECOTOX, PubMed, e-Chemportal, clinicaltrails.gov, EFSA etc.
- Basic knowledge of eco/environmental toxicity (e.g. biodegradation, toxicity to daphnia, fish (acute and chronic), toxicity to algae)
- The ability to plan, execute, monitor and interpret toxicology studies
- Able to work cross-functional teams to coordinate and manage pre-clinical activities
- These activities also include the development of nonclinical sections for IND, IB, and NDA submissions as well as interactions with regulatory agencies.
- Operational expertise in CDISC SEND Operations and Quality Checks
- Knowledge/experience nonclinical data collection, analysis, and reporting in drug development and pre-clinical study processes
- Good interpersonal skills and communication (both written and verbal) skills
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