[Innovative Medicine] R&D, SpecialistManager, Clinical Pharmacology, Clinical Pharmacology & Pharmacometrics Japan

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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. The responsibilities of this position include contribution in Japan Project Teams independently.

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

For Internal Applicants

• 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 Japans 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.

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