Carol F.

Clinical Developmet，oncology、GI

 Connected and recruited key opinion leaders as leading PIs for clinical trials through registration.  Developed clinical development plans and provided medical recommendations during life cycle of clinical trials.  Led project teams to execute clinical studies including PDL1(Phases Ia, Ib, and PhaseII), VEGF2(IND filing with CDP, study protocol for phase I), Claudin 18.2(IND filing with CDP).  Drafted and reviewed clinical development plans, study protocols, investigator brochures, ICF, site initiation presentations, and clinical study reports.  Monitored and analyzed clinical data of multiple oncology trials，worked with clinical sciences managers, CRAs, investigators, and CROs for the responsibilities of medical affairs including pharmacovigilance.  Organized and presided investigator meetings and led site initiation visits with trial investigators and clinical operation managers.  Collaborated with pre-clinical scientists, academic researchers, regulatory agents, and business development teams to identify and realize potential licensing opportunities.  Kept track of competitors landscape through studying peer publications, databanks surveying, and participating professional conferences.