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DMPK Manager

Responsibilities:

  1. 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.
  2. Identify PK issues and provide immediate and appropriate solutions to address these issues.
  3. Collaborate with other team members within the group, department and company to support integrated programs.
  4. Organize Tele-conferences and communicate with clients to update the project progress and discuss results.
  5. Coach junior SDs and might involve in client hosting and other business development activities.

Qualifications:

  1. The successful candidate must have a PhD degree in Pharmacokinetics or related experience over 1~3 years in industrial area.
  2. 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.
  3. 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.
  4. The ideal candidate must have excellent communication skills, both in Chinese and in English.
  5. The position requires the mentoring/leading of lesser experienced scientists and staff. Successful track record of management skills will be a plus.