Job Region: California

  • Clinical Pharmacology leader on one or more project teams across therapeutic modalities, indications, and stages of development (stage -1 to post-marking) a more senior level candidate will also be Progam Lead
  • Interact with cross functional matrix team personnel and contribute to strategic and scientific planning and execution
  • Accountable for developing and implementing translational strategy with a focus on clinical dose, route and regimen selection
  • Analyze and interpret PK and PK/PD data from nonclinical and clinical studies using appropriate quantitative methodologies
  • Supervise and/or mentor junior scientists and contribute to process improvement with an eye towards efficiency and consistency
  • Interact with external collaborators, key opinion leaders and vendors as appropriate
  • Author clinical pharmacology reports/sections of regulatory documents and represent the function at regulatory interactions
  • Lead cross-functional process initiatives to improve consistency in deliverables and interactions with internal partners
  • Represent Clinical Pharmacology on due diligence teams upon management request
  • EXPERIENCE
  • PhD and two to nine years experience experience in Clinical Pharmacology working in a matrix environment on drug development teams (level dependent on tenure
  • Strong PK/PD skills, extensive knowledge of pharmacokinetic concepts, DMPK knowledge and pharmacokinetic analysis software (e.g., Phoenix WinNonlin)
  • Excellent writing and verbal communication skills and experience in regulatory interactions
  • Clinical Pharmacology leadership experience representing the function in both strategic and scientific team settings

Provide expert guidance on all aspects of clinical and non-clinical pharmacokinetics and clinical pharmacology Generate PK models and PK/PD models Design human PK, ADME and DDI studies and write the protocol sections related to these study components. Design non-clinical ADME studies Interact with regulatory agencies on topics related to pharmacokinetics and clinical pharmacodynamics Write appropriateContinue Reading

Director, Pharmacometrics, Bay Area CA Help apply quantitative analysis methods and PK/PD modeling techniques in developing candidate drug products through clinical development. Serve as an expert to all relevant disciplines and ensure that modeling and simulation (M&S) methods are utilized optimally in development activities. Plan and execute PK/PD M&S activities. Represent the Pharmacometrics group inContinue Reading

Sr. Scientist/Associate Director Requirements: A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering or related discipline. Level commensurate with experience Relevant PKPD experience and demonstrated impact on drug development and/or the PKPD scientific landscape. Preferred qualifications: Strong knowledge and experience in either oncology, immunology, and/or tumor immunology are highly desired. Strong knowledge and experience inContinue Reading

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