Toxicology Director

Job Description

1. Formulating and implementing toxicological screening strategies for specific projects on new macromolecule & micromolecule drugs and new drug delivery systems, evaluating the safety and druggability of early screening projects, and participating in the development of preclinical research strategies;

2. Organizing project application and registration, toxicological research and safety evaluation in accordance with regulatory requirement of NMPA/ICH/FDA and project objectives;

3. Organization, planning, implementation and management of toxicological research projects, which include those outsourced;

4. Preparing registration and application documents to be submitted to Chinese, European and American drug regulatory authorities, and working with drug administration/registration staff to communicate with reviewers.

Job Requirements

1. Holding a master's degree or above in Pharmacy, Pharmacokinetics, Biochemistry and other related majors; those having work experience are preferred;

2. Familiar with drug R&D process, and have been directly engaged in DMPK-related work; those once working in a CRO are preferred;

3. Able to independently design, complete and analyze DMPK experiments, as well as to write relevant professional reports with high proficiency in English;

4. Conscientious, highly motivated, good at communication, and well capable of learning new things and solving problems.