The?Physician?is?part?of?the?Compound?Development?Team?(CDT),?providing?oversight?and?execution?of?clinical?program?from?clinical?study?design,?protocol?and?CRF?development,?safety?and?efficacy?data?analysis?and?interpretation?and?clinical?study?report.?He/She?will?also?be?responsible?for?assessment?of?health?outcomes,?safety?monitoring.?This?position?will?be?located?in?Shanghai,?China.?
?
?
?ESSENTIAL?FUNCTIONS:?
???Support?Clinical?Leader?by?providing?key?medical?input?and?health?economics?aspects?including?clinical?functional?plan,?clinical?challenge?sessions,?clinical?stage?gate?reviews,?operational?planning?documents
???Responsible?for?communication?of?key?clinical?assumptions,?risks?and?mitigation?strategies?by?study/project
???Responsible?for?quality?and?timeliness?of?clinical?study?design?and?protocol?generation?with?incorporation?of?health?economics?sections?in?the?protocol,?analysis?and?reports
???Select?health?outcomes?assessment?instruments?and?provides?to?CRF?design?group??
???Responsible?for?optimal?study?conduct?including?appropriate?safety?monitoring?and?meeting?regulatory?guidelines?and?timelines?for?clinical?study?safety?reporting
???Responsible?for?high?quality?data?collection,?optimal?review?and?interpretation?of?study?data,?safety?data,?health?outcomes?and?quality-of-life?data?during?the?trial?conduct?and?efficacy?and?safety?data?as?well?as?health?outcomes?data?following?data?analysis
???Responsible?for?maintaining?scientific?expertise?in?therapeutic?area?concordant?with?current?knowledge?and?practice
???Under?the?guidance?of?Clinical?Leader/Medical?Leader,?works?with?PGSM?with?publication?planning,?key?opinion?leader?development,?congress?activities?and?advisory?board?support