Japan Clinical Scientist, TA Immunology, Clinical Development

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Clinical Development & Research – Non-MD

Job Category:
Scientific/Technology

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

For clinical development strategy in Japan

Ÿ 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.

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

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 input 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.

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 ...