General Summary:
- Develop and execute Modeling & Simulation (M&S) strategies and activities in cross-functional drug development teams.
- Plan and perform technically challenging analyses using state-of-the-art M&S methodologies to support critical decision making.
Key Duties And Responsibilities:
- Serve as M&S lead in one or more cross-functional teams; develop and execute integrated M&S plans and analyses.
- Use M&S to support decisions 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.
- Improve M&S capability by supporting training and evaluating/incorporating new M&S tools.
Knowledge And Skills (Required/Preferred):
- Specialized understanding of biology, pharmacokinetics, and quantitative pharmacology (PKPD).
- Strong hands-on experience with population PK/PKPD modeling, mechanistic PKPD modeling, clinical trial simulations, and disease progression modeling.
- Proficiency with NonMem, PsN, R, Phoenix, and similar tools.
- Demonstrated leadership (collaboration/influencing) and excellent verbal/written communication.
- In-depth experience integrating PK/PD modeling and/or modeling of complex biological systems in clinical development teams.
Education And Experience:
- Masterβs or PhD (preferred: pharmaceutical sciences, pharmacometrics, math, statistics, or related quantitative discipline with pharmacometrics/PKPD emphasis).
- Typically requires: PhD + 6 years, or Masterβs + 10 years applying pharmacometric and modeling methodologies in drug R&D (industry/academia/regulatory).
Pay Range:
- $168,000β$252,000 (eligible for annual bonus and annual equity awards).