JOB SUMMARY: Briefly state the objective of this position.

JCS supports Japan Clinical Lead (JCL) activities in the development and execution of clinical development strategy for target indication(s) in assigned compound(s) to obtain regulatory approval in Japan.

Based on the Japan clinical development plan in alignment with global development strategy, JCS conducts planning/execution/reporting of clinical studies and health authority interactions on clinical matters under

the supervision of JCL.

KEY RESPONSIBILITIES: List major responsibilities and duties of the position

For clinical development strategy in Japan

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

Supports JCLs to develop clinical data package, design or select clinical studies constituting the clinical data package.

Ø For global study (under the supervision of JCL and/or Clinical group manager(C-GM))

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

o Assess clinical feasibility with local medical needs for Japan participations. Provides in put to global clinical team(CT)and compound development team(CDT).

o Request to incorporate Japan local medical and regulatory needs if needed to fulfil Japanese medical and regulatory needs.

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

o Oversees study setup and execution to ensure that the study is executed according to the protocol and required Japanese data can be obtained (including but not limited to Japan specific activities for IMPs and NIMPs).

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

o Provides medical monitoring support for Japanese participants if needed.

Ø For Local/regional study (under the supervision of JCL and/or C-GM)

o Designs study and develops PED/protocol(s).

o Establish Efficacy and/or Safety and/or Diagnosis Committee if needed.

o Reviews study related documents including Statistical Analysis Plan (SAP) /Data Presentation Specification (DPS), Japanese translated IB and ICF, IDMC charter (if necessary), analytical risk based

monitoring plan, criteria of protocol deviation plan, medical review plan and CRF completion guidelines.

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

o Oversees study setup and execution to ensure that the study is executed according to the protocol and required Japanese data can be obtained.

o 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.

o Develops protocol amendments if needed.

o Responds to protocol or clinical related queries from sites if needed.

o Reviews top line result and interprets the clinical data.

o Leads development of Clinical Study Report (CSR).

o Reviews primary publication of clinical study data and contribute to discussion on secondary publications if necessary.

Ø For health authority interaction(under the supervision of JCL and/or C-GM)

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.

Supports PMDA inspection clinical matters.

Supports development of Risk Management Plan and, J-package insert.

Supports pricing negotiation.

[PG 25]

PG 25 JCSis capable of managing clinical studies with minimal support from JCL