ãJanssenã R&D Japan Clinical Lead (JCL)_Solid Tumors Therapeutic Area
ãJanssenã R&D Japan Clinical Lead (JCL)_Solid Tumors Therapeutic Area
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
5years of pharmaceutical industry experience overall including clinical study
experienceat least three years. Preferable to demonstrate leadership in two or
moredevelopment programs which led to successful clinical trial execution and
registrationin Japan.
SolidTumors related experience is highly regarded.
-Strong oral and written communication skills in both English and Japanese.
-Good planning and tracking skills.
-Demonstrates influence negotiation and conflict resolution skills includingthe
abilityto influence without clear reporting authority.
-Good problem solving skills for developing creative solutions
-M.S. or equivalent is required (M.D. Ph.D. preferable)
AssociateDirector Clinical Development Department- Solid Tumors TA (TA-Dev) ClinicalScience Division Japan R&D Janssen Japan.
JCLis accountable for all scientific discussion/deliverables especially studydesign and outlines study results and clinical data package in clinicalstudies in the assigned compound(s) from early to post-marketing that JCoT isresponsible. JCL is responsible to execute designing implementation andcompletion of clinical studies fulfilling clinical data package for appropriateNew Drug Application (J-NDA) submission and is also responsible to executeappropriate communication with PMDA with regard to clinical studies; e.g. PMDAconsultation J-NDA submission etc.
Compoundlife cycle management:
Executes R&D publications based on the agreed R&Dpublication plan.
Developmentplanning and execution:
Creates revises and maintains study design and outlinesscientific rationale Protocol Element
Document (PED) and full protocol of the clinical studiesaligned with the clinical study plan.
Provides leadership to implement study protocol includingknowledge transfer to JCOL execution of clinical study oversight of clinicalstudies in Japan and also to prepare for the following documents:
- Investigators Brochure(IB) Japanese translated version.
- FAQ on patient eligibilityor other medical issues and potential concerns during execution of clinicalstudy in Japan.
- Summary of thecompensation system for subject health injury in Japan.
- Major protocol deviationcriteria if any.
- Medical monitoringplan/medical review plan if any.
- Statistical Analysis Plan(SAP)
- Analytical risk basedmonitoring plan
- Related other documents toclinical studies
- Training materials forJCOL and study operation team involved.
Provides leadership to execute medical monitoring whileconducting independent clinical study in Japan (Local study).
Providesleadership to execute risk and feasibility assessment of full protocol of thestudies including impact assessment of unapproved in Japan out of scope inJ-labelling imported drugs regardless approval in Japan.
Provides leadership to create Clinical Study Report (CSR)of the Local study relevant parts of
Common Technical Document (J-CTD) including discussion onappropriate data interpretation from top line results and tabulations and keymessage clarification.
Provides leadership to file CTD as JNDA includinglabeling discussion.
Executes own authority defined in the authorizationmatrix attached.
Postmarketing activities:
Supports to develop risk management plan including postmarketing surveillance studies led by
- If post marketing clinicalstudy in Japan is considered practical support will be necessary by JCL.
Reportinglines and talent pipelines:
Provides feedback regarding Japan Clinical Scientists andStudy Responsible Physician (in case of the Local study) to be reported to theAssoc. Dir.
Spanof Control:
-Budget: not applicable.
-Headcount: not applicable.
-JCL is assigned every indication done as Study Responsible Scientist (SRS) inthe Local study.
Employment Type
Full Time
