cartermackay.com Clinical Pharmacologist—CO
- 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
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