Ensure successful conduct and integrity of all in-scope clinical studies (, providing medical monitoring)
Co-owners of clinical study delivery (with Stats and Clinical Operations)
Development documents (CIB, protocol and CSR, ETC) content owner
Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary)
Forming and running advisory board for portfolio projects; Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design
Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables
Protocol development preparation for review by the Clinical Challenge and Protocol Review Commi...