Associate Director, Quantitative Systems Pharmacology

About the role

Develop and apply QSP models to guide clinical study designs and mechanistic interpretation of study results in support of development of treatments and combination of treatments for a variety of diseases and therapeutic areas.

Responsibilities

• 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 and improve our understanding of disease mechanisms
• Serve as QSP modeling & simulation point-of-contact in on project teams to solve challenging problems in drug research and development; contribute to preclinical and clinical study design and mechanistic interpretation of data
• Develop and/or utilize state-of-the-art mathematical tools to gain insight into causal relationships between individual components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction
• Analyze and interpret complex data sets in the context of disease mechanisms and pathways
• Explore new QSP opportunities in combining QSP with other analytical approaches and build synergies through collaboration with computational groups including human genetics and functional genomics
• Provide both scientific and strategic expertise in oncology therapeutic area to facilitate, develop and deliver quantitative support for decision making in clinical development programs
• Perform scientific rigor and biological suitability assessment of QSP models and methodologies through establishing a context-driven verification & validation process (reviewing QSP model goals, assumptions, methodology, model code, model outputs, uncertainty quantification)

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), and how these can be applied in the development of complex models of biological pathways and systems
• 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

Qualifications

• Familiar with mathematical modelling methods, guidelines, and best practices, as well as associated technology
• Familiar with drug development practices, especially within the area of oncology

Skills

• Strong problem-solving and critical thinking skills
• Excellent communication and collaboration skills
• Ability to work independently and as part of a team
• Proficiency in mathematical and statistical software

Benefits

• Comprehensive health care and other insurance benefits
• Retailer-based retirement benefits
• Paid holidays, vacation, and paid caregiver/parental and medical leave

Pay

The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role.

Schedule

Full-time