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Senior Pharmacokineticist - Home based

Company: Covance
Location: Madison
Posted on: August 17, 2019

Job Description:

Job Overview Covance is a drug development service company that, through unique perspective and precise delivery, has helped bring 49 of the top 50 best-selling drugs on the market today from potential into reality. Covance Pharmacokinetics department, a part of Clinical Pharmacology Services (CPS), focuses on the movement of a chemical (drug) into, through, and out of the body-the time course of its absorption, bioavailability, distribution, metabolism, and excretion. We are seeking a Senior Pharmacokineticist to join our team. The Senior Pharmacokineticist will develop PK Analysis Plans, to include methodology, definition of derived variables and data-handling rules. You will have the opportunity to make an impact on the lives of patients, partner with and learn from supportive colleagues and industry leaders, and open up new opportunities for career growth. This is a home-based opportunity and can be located anywhere in the US. Duties and Responsibilities:

  • Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK and PD analysis and study objectives.
  • Perform QC/review of analysis
  • Responsible for PK and PD deliverables within assigned projects.
  • Conduct non-compartmental PK and PD analyses as specified in the report and analysis plans.
  • Conduct compartmental modeling/simulation of PK, PD and PK/PD data and provide interpretation of the results.
  • Provide PK and PD guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for PK and PD input to protocol.
  • Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
  • Conduct interim PK and PD analyses, interpret the data and attend dose escalation teleconferences to support dose progression in allocated studies.
  • Contact with client across multiple disciplines.
  • Contribute to proposal activities and client presentations.
  • Represent the department during project-driven client audits.
  • Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP. Education/Qualifications
    • Bioanalytical Chemistry or a Biological Life Sciences Degree; advanced degree preferred Experience
      • 5 years of postgraduate experience in the application of PK and PD to clinical trials
      • Proficient in compartmental /non-compartmental data analysis
      • Specialist in WinNonLin
      • Effective interpersonal and communication skills
      • Cooperative, team-oriented, self-motivated and proactive
      • Proven ability to plan, prioritize, and manage a workload in a fast-paced environment
      • Ability to adhere to strict guidelines and codes of practice
      • A good knowledge of Clinical Development
      • Competence in the preparation of Pharmacokinetic Analysis Plans, analysis, reporting, etc., across a variety of trials
      • Ability to explain PK and PD concepts to non-pharmacokineticists

Keywords: Covance, Madison , Senior Pharmacokineticist - Home based, Other , Madison, Wisconsin

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