Medical Manager/Director 部门:Clinical Development  工作类型:Full time, Employee
工作地点:Shanghai, China
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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 experienceTitle and compensation commensurate with qualifications and experience
  • Proactive and organized with exceptional follow-up
  • Anticipate/ identify problems and takes appropriate action to correct
  • High degree of accuracy with attention to details
  • Willing and able to learn quickly in a fast-paced environment
  • Excellent team player