[Janssen] R&D, Clinical Development Immunology TA, Clinical Lead - 2406203973W

Description

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

JOB SUMMARY:

JCL is a member of Japan Compound Team (JCoT) and leads Clinical Team (CT) when assigned.

• JCL 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 clinical development strategy, JCL is responsible for planning/execution/reporting of clinical studies and health authority interactions on clinical matters.

• Sr. CL is responsible for maintaining high quality of clinical documentation sufficient to obtain regulatory approval by reviewing documents generated by CL or CS.

• Sr. CL supports talent development of CL and CS on clinical development skills.

KEY RESPONSIBILITIES:

JCL leads clinical development by proactively generating and expressing his/her opinion, and involving right stakeholders to make a decision as the CT

[CL, Sr. CL]

Accountability for clinical data

Accountable for interpretation of all clinical data in assigned indication(s) and compound(s)

Presents scientific and clinical information, and leads clinical discussions with internal/external stakeholders including health authorities

Responsibilities for clinical development strategy

Develops clinical development strategy of target indication which fulfills Target Product Profile (TPP)/target label and target New Drug Application (NDA) submission timeline mainly by leading relevant CT

Develops clinical data package, designs local/regional studies or selects Global studies constituting the clinical data package mainly by leading relevant CT.

Responsibilities in Global study

Study planning

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

OAssess clinical feasibility with local medical needs for Japan participation. Provides input to global CT and compound development team (CDT).

ORequest to create local amendment if needed to fulfil Japanese medical and regulatory needs.

Study Execution

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

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

OReviews study related documents including Japanese translated Investigators brochure (IB) and Informed Consent Form (ICF) with clinical and scientific point of view.

OProvides medical monitoring support for Japanese participants if needed

OExecute safety monitoring and assessment as one of core members of J-SMT

Responsibilities in Local/regional study

Study planning

ODesigns study and develops PED/protocol(s)

OEstablish Efficacy and/or Safety and/or Diagnosis Committee if needed

OReviews 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

Study execution

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

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

OConducts 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.

OExecute safety monitoring and assessment as one of core members of J-SMT

OHe or she can be also regarded as Study Responsible Scientist (SRS) of assigned local/regional study after taking the curriculum training.

Study report

OReviews top line result and interprets the clinical data

OLeads development of Clinical Study Report (CSR)

ODevelops R&D publication plan with MAF and executes R&D publications based on the agreed R&D publication plan

OLeads 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.

Supports PMDA inspection on clinical matters.

Supports development of Risk Management Plan and J-package insert

Supports pricing negotiation

Responsibility for KOL management

Identifies R&D related KOLs and appropriately communicates for clinical development

[Sr. CL only]

Responsible for maintaining high quality of clinical documentation sufficient to obtain regulatory approval by reviewing documents generated by CL or CS

Responsible for planning and executing organizational activities to improve efficiency and clinical quality of JJRD

Responsible for talent development on clinical development skills and appropriate clinical judgement

Qualifications

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

JOB SUMMARY:

JCL is a member of Japan Compound Team (JCoT) and leads Clinical Team (CT) when assigned.

• JCL 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 clinical development strategy, JCL is responsible for planning/execution/reporting of clinical studies and health authority interactions on clinical matters.

• Sr. CL is responsible for maintaining high quality of clinical documentation sufficient to obtain regulatory approval by reviewing documents generated by CL or CS.

• Sr. CL supports talent development of CL and CS on clinical development skills.

KEY RESPONSIBILITIES:

JCL leads clinical development by proactively generating and expressing his/her opinion, and involving right stakeholders to make a decision as the CT

[CL, Sr. CL]

Accountability for clinical data

Accountable for interpretation of all clinical data in assigned indication(s) and compound(s)

Presents scientific and clinical information, and leads clinical discussions with internal/external stakeholders including health authorities

Responsibilities for clinical development strategy

Develops clinical development strategy of target indication which fulfills Target Product Profile (TPP)/target label and target New Drug Application (NDA) submission timeline mainly by leading relevant CT

Develops clinical data package, designs local/regional studies or selects Global studies constituting the clinical data package mainly by leading relevant CT.

Responsibilities in Global study

Study planning

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

OAssess clinical feasibility with local medical needs for Japan participation. Provides input to global CT and compound development team (CDT).

ORequest to create local amendment if needed to fulfil Japanese medical and regulatory needs.

Study Execution

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

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

OReviews study related documents including Japanese translated Investigators brochure (IB) and Informed Consent Form (ICF) with clinical and scientific point of view.

OProvides medical monitoring support for Japanese participants if needed

OExecute safety monitoring and assessment as one of core members of J-SMT

Responsibilities in Local/regional study

Study planning

ODesigns study and develops PED/protocol(s)

OEstablish Efficacy and/or Safety and/or Diagnosis Committee if needed

OReviews 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

Study execution

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

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

OConducts 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.

OExecute safety monitoring and assessment as one of core members of J-SMT

OHe or she can be also regarded as Study Responsible Scientist (SRS) of assigned local/regional study after taking the curriculum training.

Study report

OReviews top line result and interprets the clinical data

OLeads development of Clinical Study Report (CSR)

ODevelops R&D publication plan with MAF and executes R&D publications based on the agreed R&D publication plan

OLeads 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.

Supports PMDA inspection on clinical matters.

Supports development of Risk Management Plan and J-package insert

Supports pricing negotiation

Responsibility for KOL management

Identifies R&D related KOLs and appropriately communicates for clinical development

[Sr. CL only]

Responsible for maintaining high quality of clinical documentation sufficient to obtain regulatory approval by reviewing documents generated by CL or CS

Responsible for planning and executing organizational activities to improve efficiency and clinical quality of JJRD

Responsible for talent development on clinical development skills and appropriate clinical judgement

Primary Location Asia Pacific-Japan-Tokyo-To-Chiyoda

Organization Janssen Pharmaceutical K.K. (7195)

Job Function Clinical Development & Research & Non-MD

Req ID: 2406203973W