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•Japan Clinical Lead is responsible for development and execution of clinical development strategy for target indication in assigned compound to obtain regulatory approval in Japan

• Based on the Japan clinical development plan in alignment with global development strategy, Japan Clinical Lead is responsible for planning/execution/reporting of clinical studies and health authority interactions on clinical matters


• Senior Japan Clinical Lead is responsible for maintaining high quality of clinical documentation necessary and sufficient to obtain regulatory approval by reviewing documents generated by JCL or Japan Clinical Scientist (JCS).


• Senior Japan Clinical Lead supports talent development of JCL and JCS on clinical development skills

Responsibilities for clinical development strategy in Japan

• Develops clinical development strategy of target indication which fulfills Target Product Profile (TPP)/target label and target New Drug Application (NDA) submission timeline.


• Develops clinical data package, designs local/regional studies or selects Global studies constituting the clinical data package.

Responsibilities in Global study

•Reviews study plan and design [i.e. Protocol Element Document (PED)/protocol(s) or any relevant study design information].

•Assess clinical feasibility with local medical needs for Japan participation. Provides input to global clinical team (CT) and compound development team (CDT).

•Request to create local amendment if needed to fulfil Japanese medical and regulatory needs.

•Develops clinical section on Clinical Trial Notification (CTN) and responds to clinical related queries from PMDA

•Partners with clinical operations for study setup and execution to ensure that the study is executed according to the protocol and required Japanese data can be obtained.

•Reviews study related documents including Japanese translated Investigator’s brochure (IB) and Informed Consent Form (ICF) with clinical and scientific point of view.

•Participates in Clinical Functional Trial Team (CFTT) meeting or other relevant venue (detail tbd) for each study as Japan representative and provides inputs from Japan perspectives

•Provides medical monitoring support for Japanese participants if needed

•Executes safety monitoring and assessment as one of core members of J-SMT

Responsibilities in Local/regional study

•Designs study and develops PED/protocol(s)

•Establish Efficacy and/or Safety and/or Diagnosis Committee if needed

•Reviews study related documents including Statistical Analysis Plan (SAP)/Data

•Presentation Specification (DPS), materialsIDMC charter (if necessary), analytical riskbased monitoring plan, criteria of protocol deviation plan

•Develops clinical section on Clinical Trial Notification (CTN) and respond to clinical related queries from PMDA

•Partners with clinical operations for study setup and execution to ensure that the study is executed according to the protocol and required Japanese data can be obtained

•Conducts medical monitoring with support from Study Responsible Physician and takes necessary measures such as amending the protocol to ensure subject safety and appropriate collection of clinical data.

•Executes safety monitoring and assessment as one of core members of J-SMT

•Reviews top line results and interprets the clinical data

•Leads development of Clinical Study Report (CSR)

•Develops R&D publication plan with MAF and executes R&D publications based on the agreed R&D publication plan

•Leads primary publication of clinical study data

Responsibilities for health authority interaction

• Develops clinical section of Briefing Book for PMDA consultation(s)


• Develops clinical section of Common Technical Document (CTD)


• Generates responses to clinical inquiries from health authorities


• Generates documents for Orphan Drug Designation if applicable.


• Prepares and responds tos PMDA’s inspection on protocol-related matters and supports clinical matters.


• Supports development of Risk Management Plan and J-package insert by cross-functional team


• Supports pricing negotiation from clinical and/or scientific viewpoints

Accountability for clinical data

• Accountable for interpretation of all clinical data at the levels of assigned indication(s) and/or compound(s)


• Presents scientific and clinical information, and leads clinical discussions with internal/external stakeholders including health authorities

Responsibility for KOL management

• Identifies R&D related KOLs and appropriately communicates from clinical development viewpoints

• Responsible for maintaining high quality of clinical documentation sufficient to obtain regulatory approval by reviewing documents generated by PG30 JCL or PG24/25 JCS • Responsible for planning and executing organizational activities to improve efficiency and clinical quality of JJRD • Responsible for talent development on clinical development skills and appropriate clinical judgement