职位描述
61 Lead to design, conduct and report pharmacokinetics (PK), toxicokinetics (TK), tissue distribution and excretion studies in small and large animals including study designs, LC-MS/MS bioanalytical method development, sample analysis, data modeling and analysis, reporting, interpretation and application to integrated drug discovery projects.
61 Lead the bioanalytical method development and non-GLP validation of LC-MS/MS methods for discovery and regulatory PK/TK studies.
61 Direct IND-enabling PK/TK studies including study protocol, report and writing and review according to regulatory technical guidelines (US FDA, China NMPA, EMA, ICH) under a GLP-like setting.
61 Develop new PK assays as needed to address specific project or study issues, or new service capability.
61 Keep up to date with emerging new mass spectrometric technologies, new animal surgery and formulation delivery technologies, and regulatory technical guidelines.
61 Communicate effectively in Chinese and English with clients for study update, project management, and technical and business development support.
61 Communicate effectively with functional groups or departments. Set priority for the lab and allocate appropriate human resources/work schedule to ensure timely report delivery

任职要求
61 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.
61 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.
61 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.
61 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.
61 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.
61 Working knowledge in regulatory guidelines in CYP- and transporter-mediated drug-drug interactions, in vitro – in vivo correlation analysis (USFDA, NMPA, EMA).
61 Working knowledge in exploratory toxicity studies (MTD, DFR/TK), clinical pathology and histopathology in small and large animals.