Senior Bioanalytical Clinical PK Representative

4 weeks ago

San Diego, California, United States Zentalis Full time
Job Summary

The successful candidate will serve as the bioanalytical clinical PK representative across multiple oncology projects at the discovery and IND-enabling stages of development. The individual will provide support to fast-paced cross-functional teams in the design, execution, analysis, reporting, and troubleshooting of DMPK assays and assay data.

Key Responsibilities
  • Design, execute, and troubleshoot clinical pharmacology studies with CROs to support internal discovery groups.
  • Analyze, interpret, report, and present DMPK/ADME data at internal program meetings.
  • Identify and maintain close relationships with CROs that conduct a range of in silico, in vitro, and in vivo studies.
  • Perform pharmacokinetic and pharmacodynamic modeling and simulation using software such as WinNonlin or R.
  • Provide oversight for DMPK/clinical pharmacology-related sample management activities, including management of BA CROs.
  • Contribute to the preparation of bioanalytical sections of IND/BLA documents.
  • Attend project meetings and manage timelines for coordinating BA and CRO work.
  • Responsible for review and approval of data/report from both BA and CRO labs in coordination with the CRO BA PI and PM.
  • Lead scientific review and provide instructions on bioanalysis at CROs to provide quality data/reports within specified timelines.
  • Supervise, manage, and strategic planning on objectives and prioritization with BA CROs to deliver robust and reliable bioanalytical assays.
  • Independently perform PK/PD analysis, IVIVCs, DDI risk assessments, human dose projections.
  • Contribute to authoring, editing, and review of documents for regulatory submissions.
  • Independently manage workload and expectations according to company portfolio priorities.
  • Other duties and projects as assigned.
Requirements
  • PhD in pharmacokinetics, drug metabolism, pharmaceutical sciences, analytical chemistry, or closely related discipline with a minimum of 6 years of experience in biotech/pharmaceutical field or MS with 8 to 12 years of experience in leading and managing a bioanalytical function within a corporate setting.
  • Extensive understanding of DMPK/ADME concepts and application in drug development settings, including but not limited to IVIVC, DDI risks, PK/PD assessment, dose projections, etc.
  • Ability to effectively interact with cross-functional teams consisting of project management, medicinal chemists, biologists, pharmacologists, toxicologists, regulatory, and clinical.
  • Proactive, innovative, superb problem-solving skills, and willingness to improve upon existing strategies.
  • In-depth knowledge of bioanalytical methods to assess PK and disposition of small molecules.
  • This candidate should be a driver of innovative scientific research and development on bioanalysis.
  • Experience in writing and reviewing validation/bioanalytical reports for regulatory filing.
  • In-depth knowledge of ICH and health authority guidances.
  • Experience in providing DMPK support to regulatory teams, including co-authoring of documents, for INDs, CTAs, NDAs, beneficial but not required.
  • Demonstrated ability to effectively manage CROs.
  • Proficient in using latest analysis and modeling software.
  • Excellent oral, written, and presentation skills with the ability to stay organized across multiple projects.

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