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Director of Clinical Pharmacology

Company: Spectrum Pharmaceuticals Inc.
Location: Irvine
Posted on: July 14, 2019

Job Description:

SUMMARY


  • Provides expertise on pharmacokinetics and pharmacodynamics on designated clinical development programs

  • Provides Clinical Pharmacology support addressing global regulatory queries and labeling needs.

  • Implements the use of quantitative approaches to integrate knowledge of pharmacokinetics, pharmacodynamics, and patient characteristics for dose selection, new indications, pediatric development and product defense.

    RESPONSIBILITIES


    • Provides clinical pharmacology leadership on multi-disciplinary teams for cancer and immuno-oncology programs including pre-clinical evaluation of lead compounds to satisfy regulatory requirements

    • Provides clinical pharmacology expertise at a project level (including clinical development plan) and at study level (including protocol preparation, clinical conduct, and reporting).

    • Exposure-response and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with other R&D partners.

    • Experience in developing appropriate drug interactions studies and various strategies to address drug metabolism polymorphism

    • Accountable for ensuring appropriate design and implementation of PK/PD modeling and simulation plans and interpretation of results.

    • Provides clinical pharmacology support and leadership in various regulatory interactions.

    • Responsible for addressing, writing and reviewing regulatory queries and labeling requests to support product

    • Assures that the clinical pharmacology strategy serves the overall objectives of the clinical program and is designed and executed to the highest scientific standards and delivers the data required to fulfill regulatory requirements.

    • Responsible for implementing clinical pharmacology best practices.

    • Represent clinical pharmacology to senior levels of the organization.


      Required SkillsQUALIFICATIONS


      • PhD or PharmD

      • Demonstrated success in managing clinical pharmacology activities and Enhanced Quantitative Drug Development

      • Excellent synthetic, writing and presentation skills

      • Experience in interactions with regulatory agencies globally

      • Requires excellent analytical skills

      • Ability to travel 20% of the time


        Required Experience



        • At least 10 years of drug development experience with at least 5 years in clinical pharmacology

        • Clinical pharmacology experience in EGFR TKIs or immuno-oncology highly desirable


          Job Location

          Irvine, US-CA

Keywords: Spectrum Pharmaceuticals Inc., Irvine , Director of Clinical Pharmacology, Executive , Irvine, California

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