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Clinical Pharmacology Lead

4 weeks ago

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

Zentalis Pharmaceuticals is seeking a highly experienced Clinical Pharmacology Lead to join our team. As a key member of our clinical development team, you will be responsible for providing clinical pharmacology, translational, and quantitative clinical pharmacology expertise to support the development of our pipeline.

Key Responsibilities
  • Design and implement clinical pharmacology plans using traditional and model-informed drug development approaches.
  • Evaluate and perform hands-on analysis of clinical PK/PD data, authorizing PK clinical study reports.
  • Support the development and execution of the quantitative clinical pharmacology strategy for nonclinical and clinical development teams.
  • Ensure appropriate planning and execution of data modeling/pharmacometrics activities in support of projects and perform advanced quantitative pharmacology and pharmacometrics analyses.
  • Manage external vendors to ensure high-quality M&S deliverables and adherence to planned timelines/budgets.
  • Maintain a current understanding of PK and PD literature and methodology, as well as the scientific literature related to our specific drug discovery projects.
  • Contribute to clinical development/clinical pharmacology strategy and planning for clinical programs.
  • Ensure timely and accurate communication of study results and interpretation to internal drug development teams.
  • Provide PK/PD modeling to support dosing strategies for clinical programs.
  • Write and edit dose rationale sections of clinical protocols and investigator brochures, INDs, CTAs, and NDAs.
  • Prepare Clinical Pharmacology components of regulatory submissions and represent the Clinical Pharmacology line at meetings with regulatory agencies and health authorities.
  • Ensure appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements.
Requirements
  • PhD, MD, or PharmD with relevant expertise in pharmacokinetics, pharmacology, or pharmaceutical science.
  • Minimum of 10-12 years of direct industry experience in conducting clinical-stage drug development.
  • Expert-level skills and expertise in modeling and simulation activities (NCA, population PK/PD modeling, literature meta-analyses, exposure-response analyses).
  • Expert knowledge and hands-on experience in NONMEM or Monolix, R, and/or SAS.
  • Additional experience with Stan, Phoenix/nlme, SAS, Python, Julia, or other mixed-effects software is preferred.
  • Experienced in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs, and/or significant sNDAs/sBLAs).
  • Experienced in responding to regulatory questions related to all aspects of clinical pharmacology.
  • Knowledge, skills, and abilities in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, oncology, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology.
  • Population PK/PD analysis and PBPK modeling experience.
  • Experience in working with external CROs with timely delivery of clear and accurate well-written study findings.
  • Strong knowledge of clinical drug development and FDA and ICH guidance documents is essential.
  • Excellent oral, written, and presentation skills with the ability to stay organized across multiple projects.