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Job ID :
37702BR
Location :
Japan - Tokyo
:
Job Description
  • Plan and successfully develop and execute clinical market development plan for Oncomine platform and other technologies within the Oncology vertical
  • Develop strategic and business objectives together with collaterals and other deliverables to achieve success
  • Coordination and leveraging regional/local FAS to ensure support infrastructure scales with clinical business
  • Designing, implementing and executing studies (clinical and analytical) within the Japan for research and marketing purposes as well as to attain PMDA approval/clearance for innovative in-vitro diagnostics (IVD) and regenerative medicines. This includes authoring of clinical protocols and other study documentation such as CRFs, consent forms, monitoring plans, visit reports etc.
  • Working with relevant subject matter experts, support registrations and negotiate pre-approval studies, submissions, product intended use claims and claim extensions, establishing requirements for clinical studies
  • Selecting and negotiating contracts with cooperation partners
  • Coordinating and managing opinion-leading centers
  • Serves as a resource, and participate in strategic business development activities including presentations to prospective clients, professional meetings, and other clinical business development activities
  • Provide therapeutic area/indications training for clinical teams
*IND-APAC

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