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Manager, Senior Clinical Pharmacology & Pharmacometric Scientist

Manager, Senior Clinical Pharmacology & Pharmacometric Scientist

Bristol Myers SquibbJP,Otemachi
19日前
職務内容の詳細

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Position Summary

  • Lead Japan clinical pharmacology (CP) strategy and related discussions on Japan clinical development across multiple therapeutic areas / compounds
  • Lead and manage pharmacometric (PM)-analyses and provide PM strategy for Japan clinical development
  • Train and advise junior staffs

Key Responsibilities

  • Responsible for all aspects of clinical pharmacology strategy and discussion on Japan clinical development and (s)JNDA filing of multiple therapeutic areas / compounds
  • Effectively influence team and collaborate with senior stakeholders, address complex problems and challenges with positive outlook, be able to deliver results with high level professionalism
  • Lead discussion with global CP&P and other functions in BMSKK to resolve any issues related to CP&P
  • Provide strategic inputs on pharmaceutical development to each project team as an expert of CP&P
  • Lead and manage Pharmacometricians for planning, execution and reporting in PM-analyses
  • Collaborate with global CP&P to implement new analysis environment and pharmacometric practice within BMS
  • Train other Pharmacometricians for their skill levels to be higher
  • Contribute to clinical regulatory documents from CP&P perspective
  • Negotiate with development team for planning / execution / reporting PM analyses
  • Establish cooperative partnership with global CP&P and other functions
  • Contribute to maximize the value of BMS marketed products through education of other stakeholders, publication, scientific meetings with external experts.
  • Qualifications & Experience

  • Deep / extensive knowledge on all over clinical pharmacology that is equivalent to 3-5 year-experiences as an expert of Clinical Pharmacology
  • High level Knowledge on pharmacokinetic and statistical analysis on PK, population PK and Exposure-Response analyses etc.
  • Good understanding of pharmaceutical drug development in Japan and requirements for submission of regulatory dossiers to the health authorities
  • Broad knowledge on full process of pharmaceutical development and its global regulatory guidance / guidelines
  • Good communication skills in both Japanese and English (e.g., OPA score 5.5 or higher).
  • Broad skills for pharmacometric analyses (hands-on experience with pharmacometric software, e.g., R, NONMEM, NLME, and SimCyp are preferred)
  • Demonstrate flexibility and openness to change in external environment
  • Uniquely Interesting Work, Life-changing Careers

    With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site Protocol

    BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

    Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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