亚新体育平台-亚新体育官网

Medical Manager/Director 部门:Clinical  工作类型:FTE
工作地点:Shanghai or Beijing
立即申请
职位申请

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