JANSSEN] R&D, SENIOR PRINCIPAL SCIENTIST, CLINICAL DEVELOPMENT DEPT., IMMUNOLOGY, INFECTIOUS DISEASE & VACCINE

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JOB SUMMARY.
JCL is a member of Japan Compound Development Team (J-CDT) 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.
Principal Scientist is responsible for maintaining high quality of clinical documentation sufficient to obtain regulatory approval by reviewing documents generated by CL or CS.
Sr.
Principal Scientist 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 [Principa; Scientist, Sr.
Principal Scientist] ・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 O Reviews study plan and design [i.
.
Protocol Element Document (PED)/protocol(s) or any relevant study design information].
O Assess clinical feasibility with local medical needs for Japan participation.
Provides input to global CT and compound development team (CDT).
O Request to create local amendment if needed to fulfil Japanese medical and regulatory needs.
Study Execution O Develops clinical section on Clinical Trial Notification (CTN) and responds to clinical related queries from PMDA O Oversee study setup and execution to ensure that the study is executed according to the protocol and required Japanese data can be obtained.
O Reviews study related documents including Japanese translated Investigator’s brochure (IB) and Informed Consent Form (ICF) with clinical and scientific point of view.
O Provides medical monitoring support for Japanese participants if needed O Execute safety monitoring and assessment as one of core members of J-SMT ・Responsibilities in Local/regional study ・Study planning O Designs study and develops PED/protocol(s) O Establish Efficacy and/or Safety and/or Diagnosis Committee if needed O Reviews 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 O Develops clinical section on Clinical Trial Notification (CTN) and respond to clinical related queries from PMDA O Oversees study setup and execution to ensure that the study is executed according to the protocol and required Japanese data can be obtained O 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.
O Execute safety monitoring and assessment as one of core members of J-SMT O He or she can be also regarded as Study Responsible Scientist (SRS) of assigned local/regional study after taking the curriculum training.
Study report O Reviews top line result and interprets the clinical data O Leads development of Clinical Study Report (CSR) O Develops R&D publication plan with MAF and executes R&D publications based on the agreed R&D publication plan O 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.
・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.
Principal Scientist 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 REQUIREMENTS.
Describe the requirements for the position.
Include any degrees, certifications, language, or computer skills etc.
which are required and/or desirable.
Experience/Knowledge[Principal Scientist] ・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.
[Sr.
Principal Scientist] In addition to the required experience for Principal Scientist; ・High level of expertise in clinical development and/or disease area required to manage complex clinical study environment and difficult projects, and to support CL or CS Skills/Capabilities[Principal Scientist] ・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 [Sr.
Principal Scientist] In addition to the key competencies in Principal Scientist, ・Good coaching/mentoring capability as an expert for clinical development is highly preferred.
Qualification/Certificate ・B.
.
or above is required