1 DNA Way South San Francisco, CA 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- The Pharmacometrics Scientist is responsible for the Pharmacometrics (PMx) strategy for his/her development project[s] in order to ensure that appropriate dose/route/schedule decisions are made for the patients.
- The PMx Scientist uses state of the art model-informed drug development strategies that are aligned with project needs.
- The PMx Scientist works in close partnership with Clinical Pharmacologists, Biostatisticians, Clinicians and cross-functional project teams.
- The responsibility for the Associate PMx Scientist is to perform population PK/PD models, translational models, disease models, exposure-response models, biomarker-efficacy models, clinical trial simulations, literature meta-analysis, and other state of the art modeling and simulation techniques. Based on experience and ability, the PMx Associate Scientist may also develop and/or lead the implementation of the Modeling and Simulation strategy for a disease area or project, represent PMx on cross-functional project teams.
- Other responsibilities may include contribution to department initiatives, or other duties as assigned.
- Familiarity with quantitative approaches in drug development, working knowledge of relevant modeling software (e.g. NONMEM, ADAPTII, Monolix, Matlab, R). Working knowledge of PK/PD data analyses, statistical approaches as they apply to clinical study design & analysis, familiarity with clinical study design options and/or working knowledge of relevant disease areas is preferred.
- The PMx Associate Scientist requires good communication skills, both written and oral.
Drug Development Knowledge:
- Experience/knowledge of how Clinical Pharmacology (CP) science can impact drug development is preferred.
- Based on experience and ability, the PMx Associate Scientist may lead CP teams and represent CP on cross-functional teams.
- MD, PhD, PharmD or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.