亚博APP手机登录|首页

Medical Manager/Director Department:Clinical
Joy Type:FTE
Working Location:Shanghai or Beijing
Application
Job Application

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

Your privacy is important for us. We use cookies to enhance your experience when visiting our websites: performance cookies show us how you use this website, functional cookies remember your preferences and targeting cookies help us to share content relevant to you. Select “Accept all” for giving your consent to all cookies or select “Reject all” for using only strictly necessary cookies.