Responsibilities

• Provide medical and scientific leadership to CStone’s clinical development teams 
• Contribute to clinical development and registration strategy for Cstone’s diverse oncology pipeline, especially for PD-L1 mAb in China and global markets
• Provide overall medical and safety oversight of CStone’s oncology clinical trials as assigned
• Act as a key driver to assigned clinical projects, provide medical and scientific expertise to project teams, participate in project feasibility and risk assessment
• Contribute to trial design, develop, review and revise IND/CTA documents, protocols, IB, CRF, ICF, IRB/EC documents, SAP, CSR and NDA documents
• Prepare materials for investigator meetings, participate and present in investigator meetings
• Conduct medical and safety monitoring, review clinical lab values, AEs, coding dictionaries and data tables, listings and figures
• Assist with data safety monitoring board activities
• Interact with inter-departmental and external consultants, KOLs, and regulatory agencies as appropriate

Qualification

• Graduate of an accredited medical school with at least five years of clinical development experience. Early phase oncology development experience preferred but not mandatory 
• Experience writing clinical development protocols, IB and study reports preferred 
• Experience with medical and safety monitoring
• Fluent in written and verbal English
• Title and compensation commensurate with qualifications and experience