W LI

--As an Executive Team member, to provide medical /clinical leadership to company's mile stone strategy and business development, with multiple global clinical programs development. --Provide leadership to build up and develop the relationship with KOLs, Investors, CROs, and other vendors. --Provide medical direction input and review for study design, protocol, IB and other clinical documents development. --Provide medical strategy and clinical expertise leadership to regulatory team for preparing the IND/NDA submission packages/documents to US and Ex-US regulatory agencies. --Responsible for overseeing the medical and safety monitoring from study initiation and conduct to DBL and CSR completion. --Responsible to lead the procedure of review and evaluation the study efficacy data and safety data,and CSR completion. --Responsible to manage and lead the internal Clinical and Medical teams, Regulatory Affair team, Quality management team and CMC teams, and external CROs and other vendors for company’s milestones functional delivery and operations activities.

--Established the cross functional organization structure for global clinical development and operations activities (including clinical operations, project management, regulatory, data management and statistics, medical affairs, pharmacovigilance, QC, compliance and training, etc.) for timeline, budget and resources allocation management --Provided leadership and medical expertise strategies to multiple global clinical study and post marked products development, clinical trials design, initiation, conduct and global study regulatory registration completion.

--Provided Medical leadership to overall of global clinical research study progress for multiple phase I, II, III and IV. --Provided medical guidance and safety expertise to clinical development strategy in studies and protocols design and execution; risk assessment and management. --Provided medical and clinical direction and input in the development and completion of the protocols, IB, regulatory submission documents and other clinical documents draft, review and final approval. --Led and performed medical and safety monitoring during the study initiation, conduct and completion. --Provided expertise input to database set up; Data Review Plan and CRF instruction reviewed and approved ; led data listing review and analysis, and period data report and CSR completion. --Provided medical expertise input to Safety Review Plan review and development; safety data review, SAE assessment, narratives and report review; led DMC activities; provide follow up action determination and direction. --Built and developed the professional relationship with investigators, KOL, vendors and expertise community. --Provided medical expertise response and solutions to internal and external requests

--Provided leadership to clinical study strategic planning, process monitoring and implementation. --Provided expertise input to regulatory submission document preparation. --Managed internal and external cross functional teams, to ensure high quality, on time and within designated budget deliverable for clinical programs development and implementation. --Provided medical monitoring and safety monitoring to multiple phase I, II and III clinical studies processing and safety management.

--Managed multiple therapeutics in phase I, II, III and IV clinical studies conducting and completion. --Provided medical and scientific expertise to all safety issue (AEs/SAEs) management. --Performed medical/safety monitoring. --Responsible for data review and report generation. .