Yi Cui Email & Phone Number

•Broad knowledge of drug discovery and development, in particular the clinical development across various therapeutic areas and different modalities (small and big molecules, and cell and gene therapies).•In depth knowledge of clinical development, including development of protocol, medical monitoring, IND application.•In depth knowledge of pre-clinical and clinical safety assessment and risk management, pharmacovigilance and clinical safety related industrial practice and (GLP/GCP) regulations/guidelines from ICH, OECD, FDA, EMA, and SFDA.Extensive experience in signal detection and evaluation, benefit and risk assessment, and production of regulatory documents (EU RMP/PSURs/PBRER and DSURs).•Track record of successful delivery of projects increasing operational effectiveness and business refinement.•Proven people leadership and talent management skills. •Scientific specialities: safety/clinical pharmacology, cardiovascular, neuroscience, ion channels, electrophysiology, molecular biology/pharmacology, pharmacovigilance.

Listed skills include Pharmacology, Glp, Drug Discovery, Neuroscience, and 7 others.