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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

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

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  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

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  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), materials IDMC 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

Qualifications

• 5 years of pharmaceutical industry experience overall including clinical study experience at least 3 years.
• Thorough knowledge of drug development process is required
• Preferable to demonstrate leadership in two or more development programs which led to successful clinical study execution and/or registration in Japan
• Thorough understanding and compliance with healthcare regulations/guideline and ethics is critical.
• Communication skill (oral and written) in both Japanese and English is critical
• Demonstrated ability to effectively collaborate across functional and global/regional boundaries are critical
• Sense of ownership, enterprise mindset and agility are required
• Planning, issue-solving skills for developing creative solutions and meeting project objectives are required
• Demonstrated ability of strategic thinking and contingency planning to manage

ambiguity and make decisions with incomplete information are required

• Ability to survey and interpret the scientific literature related to the assigned projects is required