[DJ] Manager(専門管理職), Japan Diagnostic Lead

ROLE SUMMARY

Japan Diagnostic Lead provides expertise and front-line help to relevant Research, Early and Late Stage Development, and Japan Medicine Teams for inclusion of diagnostics and global biomarker strategy in drug programs, provision and implementation of all relevant documents to such programs, and coordination of all downstream work, including life cycle management of diagnostics, within relevant internal- and external-facing organizations

ROLE RESPONSIBILITIES

• Leads development of companion and in-vitro diagnostics by working closely with Japan Medicine Team (JMT), Global Medicine Team (GMT), and the global member of translational sciences and diagnostics in Pfizer Oncology Division (POD)/Pfizer Research and Development (PRD).
• Serves on relevant JMT as a resource and authority to provide advice on inclusion of diagnostics or biomarker investigations as appropriate
• Responsible for timely implementation of diagnostics plans in relevant project documents for such programs in, including but not limited to, late pre-clinical through late stage development also considering the needs and regulations in Japan
• Responsible for timely delivery of high quality diagnostics required for successful regulatory approval and commercialization in Japan, including identification of external partners and program oversight
• Responsible for the operational excellence and quality of diagnostics
• Closely works with the global member of translational sciences and diagnostics to ensure all lab manuals, tissue requisition forms, CRFs and relevant diagnostics SOPs are considered and oversight at testing facilities are provided
• Serves as consultant in diagnostic development and commercialization in Japan including technical performance, timelines for development, regulatory, reimbursement, scale-up and commercialization of diagnostics
• Partners with the global member of translational sciences and diagnostics in POD/PRD, and Pfizer Japan to assist in the selection of diagnostics external partners and to manage relationships with key alliance partners, external consultants and service providers
• Evaluates diagnostics providers, commoditized as well as novel and disruptive diagnostics technologies
• Exercise leadership in formulating development strategy in Japan as a part of global strategy or lifecycle plan including follow-on companion diagnostic to maximize the value of drug products
• Partners with the global member of translational sciences and diagnostics to implement global biomarker strategy in Japan drug development

• Master or Doctoral degree in life sciences
• Previous 5+ years of relevant industry experience (either pharmaceutical company or diagnostic company)
• Detailed understanding of in vitro and companion diagnostics landscape and technologies
• Effective verbal and written communication skills (both Japanese and English) to enable building of effective customer and colleague relationships both inside and outside the organization
• Working knowledge of diagnostic development regulations in Japan, USA, EU, and other key Asian countries

• Previous industry experience relevant to diagnostics and/or translational biomarker (experience of drug/diagnostic development in oncology strongly preferred)
• Working knowledge or understanding of in vitro diagnostics requirements including QSR compliance and Class 3 medical device regulations
• Working level understanding of diagnostics platforms for in vitro diagnostics
• Previous extensive hands-on experience with the development of diagnostic assays / products in a lab environment
• Able to articulate clear and strategic goals with measurable metrics
• Self-motivated, results oriented individual who is able to work with minimal supervision
• Leadership experience and effective negotiation skills to reach agreements with a variety of interested individuals and/or parties internally and externally
• Experience with Commercial, Medical and Regional customer-facing units
• Team player who is able to articulate clear and strategic goals with measurable metrics