Regional QSE Director overseeing quality and food safety systems across the CCAR region. Partnering with stakeholders to drive compliance and continuous improvement initiatives.
About the role
- Associate Director of Quantitative Systems Pharmacology developing QSP models for clinical study designs. Collaborating with multidisciplinary teams to enhance understanding of physiological systems in oncology.
Responsibilities
- Develop and apply QSP models to guide clinical study designs and mechanistic interpretation of study results
- Build and utilize QSP models of biological, physiological, and pathophysiological processes to evaluate a disease, its pathways and progression, as well as drug candidates or treatment modalities
- Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians, QSP and nonclinical modelers, and other partner line colleagues to inform research and development programs
- Serve as QSP modeling & simulation point-of-contact in on project teams to solve challenging problems in drug research and development
- Analyze and interpret complex data sets in the context of disease mechanisms and pathways
- Provide both scientific and strategic expertise in oncology therapeutic area to facilitate, develop and deliver quantitative support for decision making in clinical development programs
Requirements
- PhD in Applied Mathematics, Engineering, Pharmaceutical Sciences, Systems Biology, or related disciplines with experience in the application of mathematical and statistical methods
- Experience working with the theory, principles, statistical aspects of mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, ordinary differential equations (ODEs)
- Computational experience with one or more modeling and simulation packages or programming languages (e.g., MATLAB, R, Julia, SimBiology, C/C++)
- Experience working with common tools for quantitative clinical pharmacology (such as NONMEM, R, WINNONLIN, Simcyp, SAS)
- Experience developing mechanistically-sound PK-PD models
- Experience translating, condensing, summarizing outcomes of modeling and simulation analyses into information that can be understood by project teams
Benefits
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
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