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(高级)临床药理经理

Design
百时美施贵宝
上海-静安区, 中国¥40,000 - ¥65,000 /月1周前

职位描述

  • Be an integral part of assigned China clinical development project teams, drive projects forward with innovative clinical pharmacology and model-based approaches for compounds across various therapeutic areas.
  • Serve as pharmacometrics rep with supervision to partner with China CPP Head and/or global counterparts to design and implement MIDD components of CPP plan, such as modeling and simulation (M&S) plans for China development, conducting population pharmacokinetic, exposure-response and other relevant pharmacometrics analyses, as well as interpreting and applying PK, PK/PD and pharmacometrics results to support clinical development and regulatory interactions in China.
  • Serve as CPP rep on DT or ST with supervision and make an important contribution to China clinical development by providing CPP strategy and plans for assigned early and late-stage projects.
  • Play a role in the plan, design, execution, and interpretation of healthy subject and patient studies conducted in early, full and life cycle stages of development.
  • Contribute to all aspects of clinical pharmacology and pharmacometrics related activities in CTA and NDA filling (including providing timely and high-quality responses to CPP related questions raised by Chinese health authority) in collaboration with global CPP counterpart.
  • Liaise with global CPP counterpart and related functional teams to keep alignment and gain support for assigned projects in China.
  • Collaborate and support on cross-functional drug development teams, regulatory submissions, and departmental initiatives.
Keywords
C++

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