Director, Quantitative Pharmacology, Clinical Pharmacology
Tasks
- Analyze PK and PKPD data
- Author and review clinical pharmacology submissions
- Collaborate on pharmacogenomics and biomarker development
- Coordinate first in human study activities
- Coordinate outsourcing of PK and PKPD analyses
- Develop clinical pharmacology protocols
- Develop regulatory filing content
- Evaluate dissolution testing and in vivo in vitro correlations
- Execute clinical pharmacology studies
- Lead clinical pharmacology study design
- Manage biopharmaceutics and bioanalytical inputs
- Manage project budgets and invoices
- Support assay development and sample management
- Support formulation development activities
- Support population PK and PKPD modeling
- Train and mentor staff
Perks/Benefits
- 401k match
- Accidental death & dismemberment insurance
- Basic life insurance
- Comprehensive medical insurance
- Dental insurance
- Flexible time off
- Long-term disability insurance
- Paid Holidays
- Paid leave
- Prescription Drug Coverage
- Short-term Disability Insurance
- Student loan assistance
- Tuition reimbursement
- Vision insurance
Skills/Tech-stack
Assay Development | Bioanalytical Chemistry | Biomarker development | Biopharmaceutics | Biowaivers | Clinical Pharmacology | Clinical Pharmacology Reporting | Clinical operations | Dissolution testing | Drug Metabolism | Drug development | Formulation development | In Vivo In Vitro Correlations | In vivo | Model-Based Drug Development | PKPD Modeling | Pharmacodynamics | Pharmacogenomics | Pharmacokinetics | Pharmacometric analysis | Phase I | Phase I Clinical Operations | Phoenix NLME | Population pharmacokinetics | Regulatory Submissions | Sample management | Statistical modeling
Education
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