- Lead the study director (SD) group or the entire large animal PK functional area including SD group, formulation group and in-life group to design and execute preclinical large animal PK studies, including preparation of protocols, communications with clients, and submission of study reports.
- Identify PK issues and provide immediate and appropriate solutions to address these issues.
- Collaborate with other team members within the group, department and company to support integrated programs.
- Organize Tele-conferences and communicate with clients to update the project progress and discuss results.
- Coach junior SDs and might involve in client hosting and other business development activities.
- The successful candidate must have a PhD degree in Pharmacokinetics or related experience over 1~3 years in industrial area.
- The ability to demonstrate excellent knowledge of DMPK principles is a must. Experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of GLP and regulatory guidelines is highly desirable.
- Experience in PK/PD data analysis including PK/PD modeling, simulation and prediction, as well as familiarity with various PK software packages, such as WinNonLin are required.
- The ideal candidate must have excellent communication skills, both in Chinese and in English.
- The position requires the mentoring/leading of lesser experienced scientists and staff. Successful track record of management skills will be a plus.