Simulations Plus is looking to solve client goals in quantitative clinical pharmacology projects by providing expert consultation, modeling, simulation, and analysis services to the biopharma industry.
Requirements
- Population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling and simulation experience
- Non-compartmental and compartmental pharmacokinetics experience
- Mechanistic physiologically based pharmacokinetic modeling and simulation experience
- Advanced PBPK, population PK, PK/PD, and exposure-response modeling and simulation as well as for noncompartmental analyses, using GastroPlus, MONOLIXSuite (PKAnalix, MONOLIX, Simulx), NONMEM, R, or other tools
- 10+ years of applied clinical pharmacology experience
- 8+ years of leading projects, programs, and scientists preferred
- Previous supervision of junior clinical pharmacologists and pharmacometricians, fellows, and students preferred
Responsibilities
- Lead and collaborate with multi-disciplinary teams to implement quantitative clinical pharmacology projects/programs and to provide clinical pharmacology and pharmacometric consultation to other company projects/programs
- Support clinical pharmacology-related components of clinical study protocols, study conduct, data analysis, and report writing with the support of colleagues
- Participate in regulatory interactions with health authorities
- Support project teams by providing clinical pharmacology and pharmacometric consulting through advanced PBPK, population PK, PK/PD, and exposure-response modeling and simulation as well as for noncompartmental analyses, using GastroPlus, MONOLIXSuite (PKAnalix, MONOLIX, Simulx), NONMEM, R, or other tools
- Apply advanced scientific knowledge and expertise to assigned programs and projects
- Responsible for appropriateness of methods, integrity of data used for analysis, and accuracy of results
- Ensure communication between the company and clients throughout project execution
Other
- Lead multi-disciplinary project teams through the successful completion of client goals.
- Regularly engage with clients regarding the strategic approach, presentation of results, regulatory implications, and messaging of findings
- Initiate and maintain positive, productive, and profitable client relationships
- Provide mentoring and feedback to junior scientists
- Serve as an expert resource for the Business Development Team
