General Summary:
The Modeling & Simulations Associate Director will develop and execute M&S strategies and activities in cross-functional drug development teams, collaborating with Clinical Pharmacology, Biostatistics, Research, and other R&D colleagues to drive critical decision-making using state-of-the-art Modeling & Simulation methods.
Key Duties and Responsibilities:
- Serve as M&S lead in one or more cross-functional drug development teams; develop and execute integrated M&S plans and analyses aligned with overall development plans.
- Contribute to decisions such as study design, dose selection, and probability of success estimation using advanced M&S methodologies.
- Independently perform mechanism-based PK/PD and population PK/PD analyses, clinical trial simulations, and other model-based analyses.
- Improve M&S efficiency/effectiveness by supporting training and evaluating/incorporating new M&S tools.
Knowledge and Skills:
- Specialized understanding of biology, pharmacokinetic and quantitative pharmacology (PKPD) principles.
- Hands-on expertise in population PK/PD modeling, mechanistic PKPD modeling, clinical trial simulations, and disease progression modeling.
- Proficiency with NonMem, PsN, R, Phoenix, and similar tools.
- Strong leadership, collaboration, influencing, and verbal/written communication skills.
- Experience integrating PK/PD modeling in clinical development and modeling complex biological systems.
Education and Experience:
- Masterβs or PhD in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or related quantitative discipline with emphasis on Pharmacometrics/PKPD.
- Typically: PhD + 6 years, or Masterβs + 10 years applying pharmacometric and modeling methodologies in drug research/development in industry, academia, or regulatory agencies.