Xu Wang

Be reponsiple for develpment of China stretegy & China dossier submission in the global projects

1. Responsible for designing phase I clinical trial and writing protocol for both small molecules and biologics, data analysis (NCA, statistical testing), writing clinical study report and preparation of regulatory filings that meet China regulatory guidelines, including investigator brochures, informed consent form, clinical overview and clinical development plan. 2. Participate in writing phase II protocol (MRCT study, targeting at autoimmune disease), amendments and protocol training. 3. Serve as project lead in one phase I study conducted in Australia, including protocol draft and finalization after discussion with multi-disciplinary team, PK statistical plan draft, PK report writing, safety report review and CSR writing.

1. Track the full progress of in vitro ADME IND project, including assay plan draft, assay performing, report writing and communication with sponsor. 2. Set up assay platform (phenotyping) and modify template of data process and report.

1. Serve as DMPK in vitro ADME representatives for IND filing projects according to the CFDA or FDA guidance, including communication with sponsor, study designing, coordination with bench scientist and analysis person for trouble shooting, reporting of project progress, preparation of study report, study documentation and experimental record inspection, to ensure the accomplishment of the IND project in a timely manner. 2. Take charge of or be involved in the outsourcing services for international pharmaceutical industries. 3. Set up the cell based platform in DMPK department, including permeability model and hepatocyte induction assay in support of drug discovery programs and IND. 4. Responsible for the management of public cell culture room and build up a reasonable and effective management system