Key Duties and Responsibilities

  • This role has the responsible for the protocol development and clinical strategy planning.
  • Conduct the protocol and ICF development with strong leadership skill and high clinical quality.
  • Collaborate with Cross functional domestic/ global members.

Required Sills and Experience

Must have:

  • 5+ years of experience as Clinical Scientist of oncology products.
  • Have experience of the protocol development and clinical strategy planning.
  • Have experience of provide CTD and CSR (clinical part) from the scratch level with related medical science and regulations knowledge.
  • Understand the related biostatistics data.
  • Have capability to work proactively in a global environment.
  • Ability to work effectively in a team/matrix environment on multiple projects.
  • Demonstrated ability to work independently with minimal supervision.
  • Cross-functional, smooth communication skills with a wide range of stakeholders
  • Business-level English

Welcome skills:

  • Experience working with PMDA.
  • D. holder in science
  • Bachelor of Science degree or higher

 

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