*Note: exact level depending on experience*
Job Summary:
The DMPK Modeling & Simulation Scientist will apply quantitative approaches in drug disposition, pharmacokinetics, and translational modeling to support discovery and development programs. The individual will integrate experimental DMPK and clinical pharmacology data with mechanistic and empirical models to inform candidate selection, predict human pharmacokinetics, support dose and regimen decisions, and enable data-driven decision-making across project teams. Depending on experience, the individual may independently lead modeling activities, shape program strategy, and serve as a quantitative partner to multidisciplinary teams. The role uses PK, PBPK, PK/PD, exposure-response, target engagement, and other translational approaches to connect preclinical findings with clinical development and support forward and back translation to next-generation candidates.
Requirements
Essential Duties and Responsibilities:
- Build and apply fit-for-purpose mechanistic and translational models (PBPK, PK/PD, target engagement (TE) to support discovery and development programs.
- Integrate in vitro, in vivo, and clinical data using mechanistic and empirical modeling approaches to support first in human dose projections, clinical study design, regulatory submissions, and clinical pharmacology modeling and simulation.
- Characterize relationships among exposure, target engagement, pharmacodynamic response, efficacy, and safety to inform therapeutic index assessments, dose and regimen selection.
- Assess the impact of formulation, absorption, metabolism, transporters, and DDIs on pharmacokinetics.
- Evaluate variability and uncertainty in PBPK, PK/PD and target engagement predictions to support program and portfolio decisions.
- Present scientific findings to project teams, governance committees, external collaborators, and regulatory agencies.
What We Would Like to See:
- Master's or Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Chemical/Biomedical Engineering, or a related field.
- Strong understanding of systems biology, physiology, pharmacokinetics and pharmacodynamic principles.
- Expertise in differential equation-based modeling and parameter estimation/optimization approaches.
- Expertise in PBPK modeling platforms such as GastroPlus, Simcyp, or PK-Sim
- Extensive hands-on experience with scripting for data handling, modeling, and statistics in R, Python, etc
- Demonstrated ability to influence project strategy through quantitative decision-making.
- Excellent communication and cross-functional collaboration skills.
Core Competencies:
- Excellent written and verbal technical communication skills
- Ability to lead, guide, and influence teams in decision-making
- Collaborative team behaviors and ability to build and sustain relationships with R&D customers and the wider scientific community
- Ability to work autonomously and collaboratively in a multidisciplinary team setting
- Passion for data-driven analysis and strong business-of-science thinking
- Ability to thrive in a fast-paced, highly matrixed environment
- Strong understanding of DMPK, PK/PD modeling, human PK, and DDI prediction strategies
- Proven track record of leading studies to enable IND filing and contributions to drug discovery
- Ability to apply quantitative skills for model-based drug development and complex issue resolution
- Proficiency in managing CROs and robust knowledge of relevant regulatory guidance
Pay & Benefits:
The anticipated base salary for this position ranges from $130,000 to $175,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance.
