Japan Clinical Lead, 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:

Role Overview

The Japan Clinical Leader (JCL) is responsible for the development and execution of the clinical development strategy for the target indication in the assigned compound, aiming to obtain regulatory approval in Japan.

Responsibilities differ slightly between PG30 and PG31 levels, with PG31 having additional leadership and mentoring duties.

Core Responsibilities

Clinical Development Strategy in Japan (PG30 & PG31)



* Develop clinical development strategy for the target indication that meets the Target Product Profile (TPP), target label, and NDA submission timeline.


* Build the clinical data package by designing local/regional studies or selecting relevant Global studies.

Global Study Responsibilities



* Review study plan/design (Protocol Element Document, protocols, relevant study design info).


* Assess feasibility considering Japanese medical needs for participation; provide input to Global Clinical Team (CT) and Compound Development Team (CDT).


* Request local protocol amendments if needed for Japanese medical/regulatory compliance.


* Develop clinical sections for Clinical Trial Notification (CTN) and respond to PMDA queries.


* Partner with clinical operations to ensure protocol compliance and collection of required Japanese data.


* Review Japanese-translated study documents (Investigator’s Brochure, Informed Consent Form) from both clinical and scientific perspectives.


* Represent Japan in Clinical Functional Trial Team (CFTT) meetings, providing input from the local perspective.


* Provide medical monitoring support for Japanese participants, if required.


* Execute safety monitoring and assessment as a core member of Japan Safety Management Team (J-SMT).

Local/Regional Study Responsibilities



* Design studies and develop PED/protocols.


* Establish Efficacy/Safety/Diagnosis Committee, if required.


* Review study-related documents (Statistical Analysis Plan, Data Presentation Specification, IDMC charter, risk-based monitoring plan, protocol deviation plan criteria).


* Develop clinical section for CTN and respond to PMDA queries.


* Partner with clinical op...