Job Description
Resonsible China Clinical Pharmacology strategy (including intensive PK, popPK, PK/PD, E-R, Immunogencitiy and QT analysis) to ensure: 1) smooth opening of late phase study in China; 2) relevant China CP regulation is fullfilled for a successful NDA registration Serves as the clinical pharmacology representative in assigned China ASTs/IEST and TARM meetings Serves as the (China) clinical pharmacology representative in assigned (global) study teams, to faciliate study execution Work closely with related asset global Clin Pharm representatives in timely exchanging the relevant information and provide advise/input from the Chinese regulatory and scientific perspectives to support asset China CP strategy and study execution Serves as the subject of expert of CP in China with close connection with global CP for professional support and collaboration A critical reviewer and contributor for China CP documents for CTA and NDA submission, such as China PK...