Senior Director, QSP/ PBPK Modeling

Responsibilities

• Lead the design, development, validation, and application of pharmacology models, including empirical (nonlinear mixed effects, exposure–response) and mechanistic models (PBPK, QSP, systems PK/PD).
• Integrate non-clinical PK/PD, efficacy, and biomarker data with emerging clinical PK/PD and biomarker data to inform human PK predictions, dose selection, and clinical trial design.
• Provide quantitative support for first-in-human (FIH), dose escalation, and proof-of-concept studies.
• Drive model-informed drug development (MIDD) strategies across programs, influencing key development and portfolio decisions.
• Partner closely with Clinical Pharmacology and Translational Medicine to ensure alignment between pharmacology modeling, bioanalytical strategies, and clinical endpoints.
• Author and review modeling sections for INDs, IBs, clinical study reports, and regulatory briefing documents, and support regulatory interactions as a subject matter expert.
• Ensure scientific rigor, documentation quality, and regulatory readiness of all modeling deliverables.
• Evaluate and implement new modeling methodologies, platforms, and best practices consistent with industry and regulatory expectations.

Qualifications and Experience

• Ph.D. in Pharmacology, Pharmaceutics, Pharmaceutical Sciences, Biomedical Engineering, Applied Mathematics, or a related quantitative discipline.
• 10+ years of relevant experience in quantitative pharmacology, pharmacometrics, or systems pharmacology within biotech or pharmaceutical R&D, with demonstrated progression to scientific leadership roles.
• Demonstrated ability to clearly communicate complex quantitative concepts to multidisciplinary, non-modeling audiences.

Pay

$281,000 - $299,000 USD