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DMPK Senior Scientist/Toxicokineticist

Company: Arrowhead Pharmaceuticals
Location: Madison
Posted on: March 17, 2023

Job Description:

-Compensation DescriptionThe base salary range for this position in the selected city is $100,000 - $160,000 annually.The PositionArrowhead Pharmaceuticals is seeking a seasoned DMPK scientist that will be joining a team of highly motivated and experienced chemists and biologists and contributing to the success of Arrowhead.Responsibilities

  • Develop in vivo and preclinical development DMPK strategies
  • Manage DMPK function including both in-house resources and CROs
  • Design, supervise and execute preclinical PK and Biodistribution studies
  • Provide discovery project teams with PK/PD expertise
  • Develop preclinical toxicokinetic (TK) plasma and tissue sampling strategies for toxicology studies including both in-house resources and CROs
  • Oversee preclinical GLP TK data analysis, interpretation, and reporting
  • Develop IND enabling preclinical GLP TK strategy to meet regulatory expectations
  • Execution of non-compartmental analysis using Phoenix WinNonlin software
  • Establish GLP compliant workflows and SOPs for TK analysis
  • Manage GLP and regulatory compliance strategy for software validation
  • Preclinical PK/PD analysis for human dose projections with application of safety margins from TK resultsRequirements:
    • PhD in Pharmacometrics, Drug Metabolism, Pharmaceutical Science, or a related discipline with at least 5 years of industry experience desired
    • Deep expertise in all areas of PK and TK, knowledge of nucleotide drugs desired
    • Direct hands-on experience and strong trouble shooting skills with in vivo studies, and Phoenix WinNonlin software
    • Knowledge of small molecule and oligonucleotide PK/PD and TK
    • PK/TK experience across multiple therapeutic areas desired
    • Extensive experience with drug development and knowledge of regulatory processes
    • Experienced with FDA regulatory guidance and communications
    • Experience writing SOPs for GLP compliant TK analysis and reporting desired
    • A strong track record of accomplishments
    • Excellent interpersonal, verbal and written communication skills -Powered by JazzHR

Keywords: Arrowhead Pharmaceuticals, Madison , DMPK Senior Scientist/Toxicokineticist, Other , Madison, Wisconsin

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