This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly.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 atJob Function
Discovery & Pre-Clinical/Clinical Development
Job Sub Function
Pharmacokinetics & Pharmacometrics
Job Category
Scientific/Technology
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description
Objective of Position
The Clinical Pharmacology (CP) Senior Scientist role within Japan Clinical Pharmacology and Pharmacometrics (CPP) is to apply and promote CP knowledge, including pharmacokinetics (PK) / pharmacodynamics (PD) analyses and principles of model-based drug development in the programs for all stages of drug development in Japan.
Main Accountabilities
Responsible for clinical study plan, PK and PK/PD analysis, and documentation of a Japanese Phase 1 study
Designs and writes clinical study protocols, analysis plans, and clinical reports of a Japanese phase I study or more complex CP study with mentoring
Responsible for clinical development strategy, clinical study design/protocol development, PK and PK/PD analysis, and documentation from CP perspective in the assigned project(s) in Japan
With mentoring, conduct data analysis and reporting of common CP contributions (e.g., PK, PD, immunogenicity) of clinical studies in Japan
Integrates all available data (both clinical and nonclinical data) to clinical development strategy from CP point of view
Evaluates and applies new data and data analyses to refine studies in the development plan
Responsible for clinical pharmacology data package for Japan NDA and responding to regulatory authority queries in the assigned project(s)
Carry out functional responsibilities in accordance with applicable SOPs, regulatory requirements, and Johnson & Johnson Credo principles
Other Accountabilities & Tasks
Collaborate with the Pharmacometrics leaders in overall CP development strategy, the design of clinical studies including modeling and simulation-based assessments for drug development in Japan
Translate quantitative knowledge into strategic opportunities with key stakeholders to drive development along with the model-based drug development principles
With mentoring, present at review /advisory / governing meetings with global CPL (e.g. CPP Review, MIDD Brainstorm)
With mentoring, author CP section of regulatory documents for J-NDA submission, responses to regulatory questions, and other types of interactions in Japan
With mentoring, represent CPP at regulatory interactions in Japan
Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals as a member of Japan Project Team
Apply appropriate regulatory (e.g., MHLW, ICH etc.) guidelines in the design of clinical development plans and studies in Japan
Apply relevant technical trainings/learnings to daily responsibilities, with focus on opportunistic delivery of value/impact
Minimum Qualifications / Experience
PhD or equivalent with minimum 2 years of relevant experiences; or MS or equivalent with minimum 6 years of relevant experience; or, equivalent level of expertise and the experience
Good knowledge and experience of drug development in one or multiple TAs
Minimum Technical Knowledge And Skills
Comprehensive understanding of requirements for various regulatory documents in Japan
Knowledge of drug development, regulatory requirements and guidelines expanded to multiple therapeutic modalities, to handle routine and non-routine work for FDA and EMA in addition to PMDA / MHLW
Ability to build and maintain effective working relationship inside and outside the department; ability and willingness to work in a cross-functional team environment
Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner
Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP)
Ability to interpret PK and PK/PD results and prepare presentations to communicate findings effectively
Strong oral and written communication skills in both Japanese and English
Other Requirements
Estimated both domestic and international travel of about 5% of time
Based on your experience and interview evaluation, the position title and level may vary.
If you are Japan employee, please read "Internal Application Guideline" in Ask GS.
Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR.
If you are Japan's employee, you are not able to apply for multiple positions at once.For Employee Referral Program (ERP), please read and understand the details of the "Internal Referral Overview" on the Ask GS and you have made a compliant referral.
Required SkillsPreferred Skills:
Clinical Data Management, Clinical Pharmacology, Clinical Trials Operations, Coaching, Consulting, Critical Thinking, Drug Development, Drug Discovery Development, Organizing, Pharmacokinetics, Pharmacology, Pharmacometrics, Program Management, Report Writing, Researching, Research Proposals, Scientific Research
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