My biotech client is expanding and seeks a preclinical scientist to take on the following tasks:
- Serve on project teams focused on developing novel therapeutic drugs and targets.
- Act as the scientific and technical reviewer for nonclinical studies performed with external collaborators or CROs.
- Write and edit nonclinical study protocols.
- Oversee review of 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, including IBs, INDs and BLAs.
- Communicate with regulatory agencies to resolve nonclinical issues.
The ideal candidate will possess the following qualities:
- MS/PhD and 2+ years of toxicological related sciences in academia or industry setting.
- Experience in organizing, analyzing, and documenting nonclinical studies.
- Ability to organize and analyze multidisciplinary data sets.
- Available to travel to CROs for study monitoring activities.
- Working knowledge of regulatory guidelines relevant to preclinical development.
- Understanding of FDA and GLP.