Accountabilities - Related Performance Indicators:

Understand Global Master Dossier for each NME and prepare its Japanese version of non-clinical section to fit the local requirement, and to address unmet medical needs clearly

・Development of strategic plan for Japanese version preperation to differentiate the product (e.g. additional data, wordings, etc)
・Implementation documentation/review process with well alignment with overall J-NDA submission timeline
・Finalize non-clinical pharmacology section for each submission in timely manner

Make value propositions for NME in the Japanese market from a biopharmaceutical perspective in collaboration with MAHA:

・Deep understanding of competitive landscape and SoC in the field
・Alignment with MAHA interms of pricing strategy
・Preparation of non-clincal paharmacology section of the pricing claims to clarify key differentiators of NME from competitors as well as from SoC in line with the pricing strategy

Act as the interface between Japan team and Global Discovery Research (non-clinical pharmacology group)

・Communicate with the non-clinical pharmacology group for each project to obtain sufficient infromation and data, which are not included in GMD, to strengthen value proposition
・Keep Japan team updated in terms of non-clinical feature of the project

Propose and plan non-clincal studies for NMEs that create meaningful differentiation from competitors and SoC

・Identify key differentiators of NME during early clinical phase
・Propose non-clinical studies if similar studies have not been conducted in house in timely manner
・Plan and lead the studies if applicable

Actively participate Development Japan

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