Associate Scientific Director, Pharmacometrics

Role Summary

Pharmacometrics analyses and insight are critical in the development of drug candidates, determination of product viability, and maximization of commercial value. As the Associate Director, Pharmacometrics, you will provide pharmacometrics expertise for high-priority clinical development programs and support quantitative decision-making through advanced modeling and simulation. You will contribute to the pharmacometrics strategy across disease areas and serve as a key scientific resource to program teams and functional partners.

Responsibilities

• Provide pharmacometrics expertise to activities throughout the drug development lifecycle and effectively collaborate with cross functional teams
• Execute advanced pharmacometrics analyses, with emphasis on PK/PD modeling and simulation and exposure-response analysis for high priority programs
• Identify opportunities where modeling and simulation can advance the understanding of pharmacokinetics, pharmacodynamics, efficacy and safety
• Contribute to Model Informed Drug Development (MIDD) activities to support dose selection, regimen optimization and clinical trial design
• Communicate the pharmacometrics analysis results to program teams to support data-driven decision-making process
• Mentor and guide Clinical Pharmacology and Pharmacometrics colleagues on pharmacometrics analyses methodologies
• Serve as a lead author and key contributor for pharmacometrics sections of clinical and regulatory documents
• Publish in scientific journals and present at internal and external scientific events

Qualifications

• PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or a related quantitative discipline
• 5+ years of relevant industry experience applying population PK/PD and other advanced quantitative methodologies to decision making
• Deep and extensive experience with advanced population PK/PD methodology
• Strong understanding of the clinical pharmacology principles and methodologies and their application in drug development
• Solid knowledge of the drug development process and regulatory expectations for pharmacometrics analyses
• Ability to interpret quantitative results and translate analyses into actionable program insights
• Hands-on experience with pharmacometrics software tools such as NONMEM, Monolix, and R
• Experience with mechanistic or systems pharmacology models is a plus