Senior Research Investigator
Bristol-Myers SquibbShanghaiUpdate time: August 26,2019
Job Description

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Primary objectives include, but are not limited to:

  • Local expert for early clinical research in specific area and responsible for representing company both internally and externally for assigned project/scientific topics.
  • Responsible for leading and managing in designing, executing and reporting of early clinical research projects in China.
  • Will play a role in the planning, design, execution and interpretation of healthy subject and patient studies conducted in early, full and life cycle stages of development.
  • This individual will provide broad pharmacometrics strategic leadership to early and late stage assets being developed in China and effectively communicate with global CP&P colleagues regarding asset strategies and scientific approaches.
  • A successful candidate will provide critical input on the design and execution of China clinical pharmacology plans as well as be responsible for reviewing modeling and simulation (M&S) plans for China development, and as needed conducting population pharmacokinetic and exposure-response analyses.
  • Responsible for all aspects of clinical pharmacology elements in CTA and NDA filling and control resources in conjunction with the headquarter clinical pharmacology organization (CP&P).
  • Lead of cross-functional China early develop team (EDT) for execution of early clinical studies for a given project(s).
  • Serve as local liaison with global clinical pharmacology organization (CP&P) and related functional teams to keep alignment and gain support for China projects
  • Will apply the PK, PK/PD and Pharmacometrics results to clinical development and cFDA interactions in China.
  • Serve as local Chinese speaking representative for CP&P elements at health authority meetings (responsible for all required CP&P information in Chinese, quality review of translations and preparation of slides, etc.). Responsible for generating all responses to CP&P related questions raised by Chinese Health Authorities in conjunction with global CP&P.
  • Contribute to local ad board meetings with scientific knowledge and leadership in CP&P
  • Support cross-functional project teams, such as China Early Asset team (CEAT) and China Development team (CDT).
  • Support and closely collaborate across the China clinical research group.
  • Will interpret and represent PK, PK/PD and other Pharmacometrics data generated during the clinical development and/or post-marketing stage;

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

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