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