Director, Quantitative Clinical Pharmacologist

Tasks

• Apply FDA and ICH guidelines to study design
• Apply clinical pharmacokinetic pharmacodynamic and modeling principles
• Collaborate to promote model informed drug discovery and development
• Conduct meta analyses to reuse data
• Coordinate cross functional work with statisticians biologists physicians and drug metabolism scientists
• Design and interpret clinical pharmacology studies
• Design clinical development program and registration package
• Develop mathematical models and run simulations
• Draft clinical trial protocols and reports and regulatory documents
• Lead clinical pharmacology and modeling and simulation activities
• Predict human dose range and recommend special population dosing
• Present model based strategy to governance boards and regulators
• Use physiologically based pharmacokinetic approaches for in silico evaluation

Perks/Benefits

• Health care and insurance
• Paid Holidays
• Paid caregiver leave
• Paid medical leave
• Paid parental leave
• Retirement benefits
• Vacation

Skills/Tech-stack

Clinical Pharmacology | Clinical trial | Clinical trial protocols | Dose optimization | Drug Discovery | Drug Discovery and Development | Drug development | Exposure-response | Exposure-response modeling | FDA Guidelines | ICH Guidelines | MATLAB | Meta-Analysis | Model-informed drug development | Modeling and Simulation | Nonmem | Pharmacodynamics | Pharmacokinetics | Physiologically Based Pharmacokinetics | R | Regulatory Submissions | Response Modeling | SAS | SimCYP | WinNonlin