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Head of Pharmacology
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- Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics.
- Work independently, with project teams and vendors to develop and execute clinical pharmacology strategies, including analysis and modeling of PK/PD samples for selection of dose/regimen for drug candidates from preclinical to IND and eventually NDA stage
- Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical, DMPK and clinical pharmacology development
- Lead method development and qualification of bioanalytical assays via LC-MS/MS and immunoassays and other platforms for clinical biomarker studies
- Contributes to the design of early and late-stage clinical trials (FIH to Submission) including:Non-compartmental analysis for human PK, PD, BM and safety data (including ADA) to guide decision making during dose escalation and dose-response clinical studies Clinical pharmacology and biopharmaceutical aspects for designing key elements trials
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