2016-08-02

+ 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 otherclinicalbusiness development activities

+ Provide therapeutic area/indications training for clinical teams

*IND-APAC

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