Senior Director, Quantitative Pharmacology
Tasks
- Apply innovative data analysis to optimize doses and study design using PK PD and patient characteristics
- Collaborate cross functionally with nonclinical pharmacology toxicology ADME clinical regulatory and CMC teams
- Develop biomarker strategy and incorporate into early phase studies
- Develop clinical pharmacology strategy and integrate into clinical development plans
- Lead model based drug development input for dose selection efficacy safety
- Oversee clinical pharmacology deliverables for all clinical phases
- Provide go no go recommendations for business development opportunities
- Review and approve clinical study design and protocols
- Review approve and lead clinical pharmacology sections for regulatory filings
- Train manage and mentor junior team members
Perks/Benefits
Skills/Tech-stack
Biomarker development | Dose selection | Drug development | Exposure-response | Exposure-response modeling | Model-Based Drug Development | Pharmacodynamic modeling | Pharmacodynamics | Pharmacogenomics | Pharmacokinetic Pharmacodynamic | Pharmacokinetic pharmacodynamic modeling | Pharmacokinetics | Response Modeling
Education
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