Modeling & Simulations Associate Director

General Summary

The Modeling & Simulations Associate Director will develop and execute M&S strategies and activities in cross-functional drug development project teams, collaborating closely with colleagues in Clinical Pharmacology, Biostatistics, Research, and other R&D organizations. This role contributes to critical decision-making through the use of advanced Modeling & Simulation methodologies.

Key Duties And Responsibilities

• Develop and execute Modeling & Simulation plans and analyses, fully integrated with overall development plans.
• Contribute to critical decision-making processes such as study design, dose selection, and probability of success estimation.
• Independently perform mechanism-based PKPD and population PK/PKPD analyses, clinical trial simulations, and other model-based analyses regularly.
• Support the continuous improvement of M&S capabilities by participating in training activities and incorporating new M&S tools as appropriate.

Knowledge And Skills

• A specialized understanding of biology, pharmacokinetics, and quantitative pharmacology (PKPD) principles.
• Excellent hands-on skills in population PK and PKPD modeling, mechanistic PKPD modeling, clinical trial simulations, disease progression modeling, etc.
• Proficiency in using NonMem, PsN, R, Phoenix, and similar tools.
• Demonstrated strong leadership skills, including collaborative and influencing abilities.
• Excellent verbal and written communication skills.
• In-depth experience working in clinical development teams and integrating PK/PD modeling and/or modeling of complex biological systems.

Education And Experience

• Master's or PhD in Pharmaceutical Sciences, Pharmacometrics, Mathematics, Statistics, or a related quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling.
• Typically requires a PhD and 6 years of experience or a Master's degree and 10 years of experience in the application of Pharmacometric and other Modeling methodologies in drug research and development.