J&J Family of Companies 【Janssen】R&D Study Responsible Physician (Medical Doctor), Hematology Clinical Development Department in Chiyoda, Japan

POSITION SUMMARY:

・Study Responsible Physician (SRP) is responsible to execute medical review of medical-related parts such as appropriate use of medical terms, medical interpretation, coding and check data quality and patient safety by overseeing medical monitoring and review which are done by Japan Clinical Scientist (JCS).

・SRP is responsible to supervise possible actions and considerations to be taken while executing the Local study against patient eligibility criteria, clinical evaluation, safety risk management, and medical monitoring plan/medical review plan.

PRINCIPAL RESPONSIBILITIES:

Development planning and execution:

・Approve contents of full protocol and its amendments, and Clinical Study Report (CSR) of the Local study, and other related documents such as informed consent form, major protocol deviation criteria, database release plan, major protocol deviation list, coding files (medical history, adverse event, and concomitant medication), medical review plan, etc.

・Provide leadership, as SRP, to review the following documents created and amended for the Local study to ensure medical appropriateness of them:

[Preparation and start-up phase]

・Protocol Element Document (PED), Full protocol

・Informed consent form

・Case Report Form (CRF)

・FAQ on patient eligibility or other medical issues and potential concerns during execution of the Local study.

・Summary of the compensation system for subject health injury.

・Criteria of protocol deviation, if any.

・Analytical risk based monitoring plan, if any.

・Medical monitoring plan/medical review plan, if any.

・Training materials for to Japan Clinical Operation Leader (JCOL) and study operation team involved in the Local study, if any.

・Documents in which review by SRP is clearly defined.

・Execute training for JCS who handles medical inquiries from JCOL, study operation team or investigators, etc.

・Approve contents of full protocol and its amendments

[Execution phase]

・Execute safety evaluation of serious adverse events.

・Execute response to medical inquiries escalated from JCS.

・Execute periodic medical coding review – medical terms, medications, etc.

・Review the following documents created and amended for the Local study to ensure medical appropriateness of them:

・Statistical Analysis Plan (SAP) its amendment.

・Amendments of full protocol

・Amendments of informed consent form

・Amendments of case report form

・Updated FAQ on patient eligibility or other medical issues and potential concerns during execution of the Local study.

・Updated summary of the compensation system for subject health injury.

・Updated criteria of protocol deviation, if any.

・Updated analytical risk based monitoring plan, if any.

・Updated medical monitoring plan/medical review plan, if any.

・Updated training materials for JCOL and the study operation team involved in the Local study, if any.

・Documents in which review by SRP is clearly defined.

・Approve contents of amendments of full protocol.

[Close-out phase]

・Review the following data and documents generated from the Local study to ensure medical appropriateness of them:

・Top line results and result summary including key messages.

・Clinical Study Report (CSR).

・Coding of medical terms which are used for the CSR

・Publication – conference poster, abstract, journal manuscript.

・Documents in which review by SRP is clearly defined.

Post marketing activities:

・Contributes to package insert (J-labelling) development, if any.

・Supports to develop risk management plan including post marketing surveillance studies led by JSS (Japan Drug Safety and Surveillance) , if any.

・Provides leadership to execute post marketing clinical study from early preparation to completion if post marketing clinical study in Japan is considered.

REPORTING RELATIONSHIPS:

Associate Director, Hematology Clinical Development Department, Oncology Area, Clinical Science Division, Japan R&D, Janssen Japan.

Qualifications

EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:

・M.D. is required.

・2 year of pharmaceutical industry experience is preferable especially clinical study experience at least one year. Preferable to demonstrate leadership in two or more clinical studies which led to successful clinical trial completion regardless of country.

・Adequate work experiences of clinical practice and/or clinical research.

・Strong oral and written communication skills in both English and Japanese.

・Good planning and tracking skills.

・Demonstrates influence, negotiation and conflict resolution skills, including the ability to influence without clear reporting authority.

・Good problem solving skills for developing creative solutions.

Primary Location

Japan-Tokyo-To-Chiyoda

Organization

Janssen Pharmaceutical K.K. (7195)

Job Function

Clinical Research MD

Requisition ID

1805632439W