Project Physician （PP） is a medical expert who is accountable/responsible for the medical science expertise to generate clinical development strategy, design clinical development options, and deliver successful clinical development of responsible products in Japan. PP is working closely with Medical Scientist （MS）. His/Her accountability/responsibility is mainly project－level, however, he/she is also involved in study－level activities as needed.
1 Project Level
1.1 Design ＆ Interpretation / D＆I
1.1.1 Lead D＆I activities to generate Japan clinical development strategy with MS and ensure that Japan medical science views are appropriately incorporated in project development strategy
1.1.2 Generate high－quality design options that characterize benefit, risk and value of medicinal products, focusing on reducing uncertainties and providing clear and transparent recommendations for decision and governance bodies.
1.2.1 Ensure and champion consistent clinical science aspects and strategies across programs.
1.2.2 Ensure optimal management of high impact project opportunities and risks.
1.2.3 Review study design, regulatory documents consistent with the clinical strategy.
1.2.4 Ensure delivering rationalized hypothesis, evidence based argument, and convincing interpretation in clinical science related documents.
1.2.5 Input scientific information to internal documentation/slides such as IDP/CDP and governance document.
1.3 PMDA interaction
1.3.1 Co－develop clinical science part of regulatory related documents with MS; e.g., PMDA consultation BD, query responses, etc., and ensure the consistency with agreed clinical strategy and medical science aspects are captured properly.
1.4.1 Review CTD and ensure the consistency with agreed clinical strategy and medical science
aspects are captured properly.
1.5 Pharmacovigilance （PV）
1.5.1 Evaluate the safety data, describing industry’s views for patient safety in CTD preparation, and
point out information required for safety narrative and DSUR.
1.6 KEE management
1.6.1 Lead key contacts with external experts and help develop clinic－scientific alliance working with
MS and global CPT.
1.6.2 Act as a key point of contact for clinical science related relationship with external experts.
【必須（MUST）】医師免許 海外医師免許 応相談