Job Region: Colorado

  • Active member of clinical study teams with responsibilities to support the design, execution and close out of Phase 1 through 4 clinical studies
  • Guides overall clinical pharmacology strategy for assigned programs, including timing and design of DDI, formulation, impairment or other studies.
  • Responsible for the model-based evaluation (e.g., PK, PK/PD, exposure-response, disease modeling) and resulting guidance for drugs within the pipeline through the application of state-of-the-art pharmacometric tools and methodologies
  • Prepares portions of clinical studies reports, worldwide regulatory submissions and other technical documents.
  • Provides oversight for contracted work related to clinical pharmacology
  • Supports discovery program(s) through data analysis and/or modeling and simulations (e.g., human predictions, PK/PD/efficacy)
  • Contributes to presentations pertaining to work being conducted for both internal and external presentation and publication
  • Maintains state-of-the-art technical skills and knowledge base.  Reads and keeps up to date with relevant scientific literature to maintain and advance knowledge
  • Makes recommendations for changes and may implement approaches and procedures to improve quality, capability or productivity
  • Interacts with technical experts from various departments, external KOLs, CROs and collaborators.
  • PhD or PharmD with 2-6 years experience or MS with 8+  years experience

CARTERMACKAY

400 Crown Colony Drive, Suite 600

 Quincy, MA 02169

T: 617-689-0029 • F: 617-689-3044

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