Director in Pharmacokinetics

工作地点：上海浦东         所属类型：AC         发布时间：2024-07-03

任职资格：

• A Ph.D. degree in drug metabolism, pharmaceutical science, organic chemistry, analytical chemistry, biochemistry, or related discipline with 12 - 15 years’ experience in pharmaceutical and biotechnological companies, or contract research organizations. The candidate with overseas experience is preferred.

• Hands-on experience in designing, conducting, analyzing and reporting PK, TK, tissue distribution and excretion studies to support preclinical projects in discovery and GLP-like settings.

• Working experience in designing and conducting IND-enabling PK/TK studies to support China NMPA and US FDA, EMA regulatory filing and associated CTD and SEND writing in a GLP-like setting.

• A thorough understanding in formulations, cassette-dosing, dose administration routes (oral, intravenous bolus and infusion, intraarterial, intramuscular, intraperitoneal, intratracheal, subcutaneous, transdermal, oropharyngeal aspiration, intrarectal, intranasal, etc.) and special delivery of test compounds in various small and large animal species (mice, rats, dogs, monkeys, rabbits, mini-pigs, etc.) and various surgery technologies (bile-duct cannulation, jugular cannulation, portal vein cannulation, carotid artery cannulation, etc.) in PK/TK studies.

• Expertise in LC-MS/MS quantitation techniques including various MS/MS and LC platforms especially AB Sciex MS/MS, Shimazu and Waters HPLC/UPLC, bioanalytical method troubleshooting.

• Working knowledge in regulatory guidelines in CYP- and transporter-mediated drug-drug interactions, in vitro – in vivo correlation analysis (USFDA, NMPA, EMA).

• Working knowledge in exploratory toxicity studies (MTD, DFR/TK), clinical pathology and histopathology in small and large animals.