Sr. ADME and Quantitative Pharmacology Director
Tasks
- Align DMPK and PK PD with development plans
- Collaborate with clinical operations and biostatistics
- Design PK PD studies
- Drive dose finding studies
- Integrate nonclinical ADME into clinical plans
- Lead DMPK strategy
- Lead PK PD strategy
- Perform PK PD analysis
- Perform exposure response modeling
- Provide PK ADME support for discovery
- Provide scientific regulatory support
- Provide stage appropriate clinical pharmacology studies
- Serve as DMPK subject matter expert
- Serve as clinical pharmacology subject matter expert
- Support IND NDA BLA filings
Perks/Benefits
Skills/Tech-stack
ADME | Biopharmaceutics | Dose finding | EMA | Exposure-response | Exposure-response modeling | FDA | ICH Guidelines | Modeling and Simulation | PD analysis | PK/PD | PK/PD Analysis | Pharmacodynamics | Pharmacokinetics | Regulatory Submission | Response Modeling | Risk Benefit Assessment | Study design
Education
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