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
