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.