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Senior Clinical Pharmacokineticist ll

Company: AbbVie
Location: Redwood City
Posted on: March 18, 2019

Job Description:

The Clinical Pharmacology and Pharmacometrics Organization (CPPM) leads the strategy, generation/analyses/interpretations/reporting of data and communications/agreements with global regulatory agencies in the areas of Clinical Pharmacology, Pharmacokinetics, Exposure-Response and Biopharmaceutics. The organization supports all phases of pharmaceutical research and development from Discovery to Development to On Market Support for all new molecular entities and marketed products in all therapeutic areas (antiviral,immunoscience, neuroscience, pain, metabolic disease, men and women's health,renal disease and oncology). The organization is responsible for defining the relationship between drug exposure (e.g., concentrations in blood) and efficacy measures (primary and/or secondary clinical outcomes or biomarkers) to select the optimal dose and dosing intervals. CPPM is also responsible for definingthe relationship between drug exposure and safety measures (clinical outcomesor biomarkers (e.g., QTc)) to identify populations that may be at risk ofincreased toxicity or decreased tolerability. CPPM performs the selection,design and interpretation of all Phase I studies including first in human, bioavailability/ bioequivalence/food effect, drug interaction, pilot/definitive cardiovascular (QTc), special population, pharmacogenetic and immunogenicity studies. The organization provides critical support for conducting technical due diligence of new business opportunities (bothin-licensing and out-licensing) by assessing probability of success for achieving Target Product Profile (TPP). CPPM contributes to responses to defend our intellectual properties and extension of patent protection, provides critical support for life-cycle management of marketed products, responds to questions from post-marketing safety, legal, pharmaceutical manufacturing and regulatory for marketed products world-wide, and publication of scientific information in patents and manuscripts. Key Responsibilities Include:

  • Develops systems pharmacology models that achieve project and therapeutic area goals. Understands PK/PD regulatory advances, strengths, weaknesses, opportunities, and threats and assists with responses and appropriate new strategies
  • Acts as a lead modeler on one or more studies and investigates, identifies, develops, and optimizes new systems pharmacology models
  • Utilizes systems modeling expertise to provide PK/PD consultation to the business and leadership on decisions and development plans for multiple projects within a therapeutic area
  • Develop productive collaborations and communications with other groups across multiple disciplines
  • Writes, communicates, presents system pharmacology materials
  • Contributes to the development of commercial and regulatory strategies by formulating modeling plans including development activities
  • Assists in the development of PK/PD plans to satisfy regulatory expectations and defend plans and interpretation of data to management
  • Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact)
  • Primary contributor to PK/PD interpretations of reports for regulatory filings and clinical protocols
  • Contributes to interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions
  • Author in peer-reviewed journals, R&D reports, and/or regulatory documents/filings
  • May contribute to due diligence P osition will be hired based on level of experience and may be hired at a lower level Basic: For Senior Clinical Pharmacokineticist II:
    • PhD in pharmacokinetics, systems biology, bio-engineering, mathematical biology or a related area
    • A minimum of 1 to 3 years of experience
    • Demonstrates technical expertise on systems pharmacology projects
    • Must have demonstrated ability to lead PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion
    • Knowledge of standard business procedures (regulatory guidance, global regulations, SOPs) For Senior Clinical Pharmacokineticist I:
      • PhD in pharmacokinetics, systems biology, bio-engineering, mathematical biology or a related area
      • Demonstrates technical expertise on systems pharmacology projects
      • Must have demonstrated ability to lead PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion
      • Knowledge of standard business procedures (regulatory guidance, global regulations, SOPs) Key Leadership Competencies:
        • Builds strong relationships with cross-functional teams to enable higher performance
        • Learns fast, grasps the 'essence' and can change the course quickly where indicated
        • Creates a learning environment, opens to suggestions and experimentation for improvement
        • Embraces the ideas of others, nurtures innovation and manages innovation to reality Equal Opportunity Employer Minorities/Women/Veterans/Disabled

          Keywords: AbbVie, San Francisco , Senior Clinical Pharmacokineticist ll, Healthcare , Redwood City, California

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