My biotech client's pipeline is thriving, and they are looking to hire a Scientist to take on the following tasks:
- Serve on project teams focused on developing novel therapeutic drugs and targets.
- Review nonclinical studies performed with external collaborators or CROs.
- Oversee nonclinical study reports and finalize study reports to ensure appropriate interpretation and reporting of data.
- Build and develop partnerships with CROs.
- Write and review nonclinical safety documentation INDs and BLAs.
- Work with FDA to resolve nonclinical issues.
The ideal candidate will possess the following qualities:
- Toxicology experience within a biotech or CRO.
- Experience in organizing, analyzing, and documenting nonclinical studies.
- Ability to organize and analyze multidisciplinary data sets.
- Working knowledge of regulatory guidelines relevant to preclinical development.
- Understanding of FDA and GLP.