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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 operations for study setup and execution.
• Conduct medical monitoring with Study Responsible Physician; implement safety measures such as protocol amendments when necessary.
• Execute safety monitoring and assessment as part of the J-SMT.
• Review top-line results and interpret data.
• Lead development of Clinical Study Report (CSR).
• Develop R&D publication plans with Medical Affairs Function (MAF) and execute agreed publications.
• Lead primary publications of clinical study data.

Health Authority Interaction Responsibilities

• Develop clinical content for PMDA consultation Briefing Books.
• Prepare Common Technical Document (CTD) clinical sections.
• Respond to clinical inquiries from health authorities.
• Prepare documentation for Orphan Drug Designation, if applicable.
• Support PMDA protocol-related inspections and respond to clinical matters.
• Contribute to Risk Management Plans and Japan package inserts through cross-functional collaboration.
• Support pricing negotiations from a clinical/scientific perspective.

Accountability for Clinical Data

• Interpret all clinical data for assigned indications/compounds.
• Present scientific and clinical information; lead internal/external discussions, including with health authorities.

Key Opinion Leader (KOL) Management

• Identify R&D-related KOLs and communicate effectively from a clinical development perspective (PG31 only).

PG31 Additional Responsibilities

• Maintain high-quality clinical documentation necessary for regulatory approval by reviewing outputs from PG30 JCL or PG24/25 JCS.
• Plan and execute organizational initiatives to improve efficiency and clinical quality in JJRD.
• Support talent development in clinical skills and judgment for PG30 JCL and PG24/25 JCS.

Requirements

PG30

• ≥5 years pharmaceutical industry experience, including ≥3 years in clinical studies.
• Thorough knowledge of the drug development process.
• Preferably demonstrated leadership in ≥2 development programs leading to successful study execution and/or registration in Japan.
• Strong compliance with healthcare regulations, guidelines, and ethics.

PG31 (in addition to PG30 requirements)

• High level of expertise in clinical development and/or disease area.
• Ability to manage complex study environments and challenging projects.
• Capability to mentor and support PG30 JCL and PG24/25 JCS.

Key Competencies

PG30

• Strong communication skills in Japanese and English (oral/written).
• Ability to collaborate effectively across functional, global, and regional boundaries.
• Sense of ownership, enterprise mindset, and agility.
• Planning and problem-solving skills to develop creative solutions and meet objectives.
• Strategic thinking and contingency planning under uncertainty.
• Ability to survey and interpret relevant scientific literature.

PG31 (in addition to PG30 competencies)

• Expertise in coaching/mentoring as a clinical development specialist.

Required Skills:

Preferred Skills:

Analytical Reasoning, Clinical Data Management, Clinical Evaluations, Clinical Trial Protocols, Coaching, Consulting, Data Savvy, Drug Discovery Development, Good Clinical Practice (GCP), Medicines and Device Development and Regulation, Persistence and Tenacity, Regulatory Affairs Management, Research Documents, Resource Management, Safety-Oriented, Scientific Research, Technologically Savvy

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