Director, Quantitative Pharmacology, Clinical Pharmacology
Tasks
- Analyze PK and PKPD data
- Author and review regulatory submission documents
- Collaborate on first in human study design
- Collaborate on mass balance and drug interaction studies
- Develop clinical pharmacology protocols
- Develop clinical pharmacology regulatory sections
- Execute clinical pharmacology studies
- Lead clinical pharmacology study design
- Manage clinical pharmacology budgets and outsourcing
- Partner on assay development and bioanalytical methods
- Provide biowaiver recommendations
- Provide pharmacometrics input
- Support formulation development activities
- Support model based drug development strategies
- Support pharmacogenomics and biomarker development
- Train and mentor clinical pharmacology staff
Perks/Benefits
- 401k match
- Comprehensive medical
- Dental insurance
- Flexible time off
- Paid Holidays
- Paid leave programs
- Student loan assistance
- Tuition reimbursement
- Vision insurance
Skills/Tech-stack
Assay Development | Bioanalytical Assay | Bioanalytical Chemistry | Bioanalytical assay development | Biomarker development | Biopharmaceutics | Biowaivers | Clinical Pharmacology | Dissolution testing | Drug Metabolism | Formulation development | In vitro | In vitro in vivo correlation | Modeling and Simulation | PKPD analysis | Pharmacodynamics | Pharmacogenomics | Pharmacokinetics | Pharmacometric Modeling | Phoenix NLME | Population PK | Protocol development | Regulatory Submissions | Sample management
Education
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