Group Leader/Senior Group Leader in in-vitro ADME

工作地点：上海浦东         所属类型：AC         发布时间：2024-02-26

任职资格：

• A M.S. or Ph.D. degree in drug metabolism, pharmaceutical science, organic chemistry, analytical chemistry, biochemistry, or related discipline with 5 - 10 years’ experience in pharmaceutical and biotechnological companies, or contract research organizations.

• Hands-on experience in designing, conducting, analyzing and reporting in vitro ADME studies (metabolic stability, CYP, efflux and uptake transporter mediated drug-drug inhibition and induction, CYP reaction phenotyping, plasma protein binding, etc.) including study designs, bioanalytical method development, sample generation and analysis, data analysis and reporting to support drug discovery and IND-enabling projects.

• Working experience in quantitative LC-MS/MS method development and sample analysis with AB Sciex API LC-MS/MS and other instruments (RT-PCR, plate readers).

• Working experience in IND-enabling in vitro ADME study designs and execution, CTD pharmacokinetics summary writing to support regulatory filing (China NMPA, USFDA, EMA) and address regulatory questions.

• Experience in leading and supervising a group of lab scientists.

• Excellent oral and written communication, interpersonal, and organizational skills is required, along with demonstrated ability to interface effectively with clients and project team members in English and Chinese.

• A thorough understanding of various small and large animal PK/TK studies are desirable.