Toxicologist

**Responsibilities**
- Select, audit and provide qualification assessment of toxicology CROs for to support drug safety programs. Supervise the progress of related projects.
- Make plans for the toxicity studies for drug molecules according to IND (Investigational New Drug) requirements of CDE (Center for Drug Evaluation).
- Design and implement project-level drug safety assessment strategy in coordination with various internal stake holders including drug discovery team, DMPK, projection management, regulatory, clinical, etc.

**Requirements**:

- PhD 5+ years after graduation or MS after 10 years of graduation in toxicology, pharmacology or related scientific discipline with of relevant experience in drug development in the bio-pharmaceutical industry.
- In-depth knowledge of drug safety assessment from drug discovery through advanced stages of drug development.
- Knowledge and experience with regulatory toxicology, ICH guidelines, and worldwide GLP regulations.
- Hands-on experience in authoring of toxicology portion of regulatory documents.
- Previous experience of toxicology for clinical programs in oncology, neurodegenerative diseases, and immune-oncology highly desired.
- Knowledge and experience one of the following area very helpful: immunotoxicity aspect of NCE, mechanistic toxicology, reproductive toxicology, MIST.