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
Related jobs
-
Assay Development | Bioanalytical Assay | Bioanalytical Chemistry | Bioanalytical assay development | Biomarker development401k match | Comprehensive medical | Dental insurance | Flexible time off | Paid HolidaysExecutive-level Full TimeRemote, United States R8d ago
-
Director of Statistical Programming USD 186K-233K21 CFR Part 11 | 510(k) | ADaM | CDISC | CFR Part 11401k benefits | Commuter benefits | Employee referral program | Fertility care benefits | Free testingExecutive-level Full TimeUS Remote R1mo ago
-
Bioanalytical Chemistry | Biopharmaceutics | Clinical Pharmacology | Drug Metabolism | Modeling and Simulation401k match | Accidental death and dismemberment insurance | Comprehensive medical | Dental insurance | Flexible time offExecutive-level Full TimeRemote, United States R1mo ago