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Position:
Senior Manager/ Associate Director, Clinical Pharmacology

Employer:
BeiGene

Description:

General Description:

The Senior Manager, Clinical Pharmacology will be responsible for developing and executing clinical pharmacology strategies for small molecules and biologics assets in our oncology portfolio, either independently or by working closely with other clinical pharmacologists. The SM is expected to be a strongly motivated individual with an excellent scientific and quantitative background with good collaborative and communication skills.

Essential Functions of the job:

  • Develop and execute clinical pharmacology, immunogenicity, pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates across all phases of clinical development. This will be accomplished working independently or in close collaboration with the lead clinical pharmacologist for the project.

  • Represent the department in study teams and develop clinical pharmacology study designs and collaborate with key stakeholders to write study protocols, amendments, and reports.

  • Contribute to the design and analysis of PK data from clinical studies.

  • Conduct hands-on clinical PK, pharmacometric data analyses and summarize, report these analyses.

  • Analyze, interpret, summarize and present data to internal project teams and to senior management.

  • Assist in authoring relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.

  • Lead or contribute to process related departmental initiatives



Qualifications/Experience:

Computer Skills :  Hands-on experience in performing NCA using Phoenix WinNonlin is essential. Hands-on experience with one or more of the following is preferred: NONMEM, R, S-Plus, Berkeley Madonna, Simcyp, Gastroplus.

Other Qualifications :  A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical sciences, Biomedical Engineering or related discipline with at least three years of industry and/or related post-doctoral experience is preferred. Demonstrable scientific and clinical development expertise based on publications and/or strong references is essential. A good understanding of global health authority guidances and filing requirements is desired. Familiarity with DMPK studies, bioanalytical methods is preferred.

Education Required:  Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline



Location: San Francisco Bay Area

Contact: ken.virdee@beigene.com

Post Date: 3/12/2021 3:24:54 PM
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