Senior Director, Pharmacometrics
Immunome, Inc.
June 25, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview
- Senior Director, Pharmacometrics to lead model-informed drug development strategies across Immunome’s targeted oncology portfolio, supporting pharmacometric analyses for clinical development decisions, dose selection/optimization, regulatory submissions, and product labeling.
Responsibilities
- Develop and implement pharmacometrics strategies aligned with program objectives, clinical pharmacology plans, and regulatory expectations.
- Lead dose selection/optimization, exposure-response assessment, and model-informed decision-making.
- Build standards for modeling, simulation, documentation, and cross-functional integration.
- Lead population PK/PK-PD/exposure-response/disease progression and model-based meta-analysis strategies for development and registration.
- Apply fit-for-purpose PBPK/QSP/translational modeling or simulation for first-in-human, dose escalation/expansion, special populations, DDI risk, and lifecycle development.
- Oversee analysis plans, model development, simulations, QC, and interpretation for scientific rigor and regulatory readiness.
- Partner cross-functionally to integrate pharmacometrics deliverables into study plans and timelines; advise on PK/PD sampling and statistical/data standards.
- Author/review pharmacometrics components of clinical pharmacology plans, analysis plans, reports, investigator brochures, CSRs, and regulatory submissions.
- Lead IND/NDA/BLA contributions, briefing book inputs, health authority responses, and labeling discussions aligned with FDA/EMA/ICH/global expectations.
- Identify and manage external pharmacometrics vendors/CROs; oversee scope, budget, timeline, technical review, and QC.
- Lead/mentor pharmacometricians; communicate findings to senior leaders and regulatory audiences.
Qualifications
- Ph.D. (12+ yrs), M.S. (15+ yrs), or B.S. (18+ yrs) in a relevant quantitative discipline (pharmacometrics/clinical pharmacology/statistics/etc.).
- Track record leading pharmacometrics strategy/execution across multiple clinical-stage programs and regulatory submission support.
- Deep expertise in population PK, PK/PD, exposure-response, simulation, dose optimization, and model-informed development.
- Global regulatory filing experience (IND/NDA/BLA, briefing book, labeling, health authority responses).
- Hands-on tools: NONMEM, Monolix, Phoenix, R, SAS, Python, MATLAB, Simcyp, GastroPlus (or similar).
- Oncology experience required; ADCs/biologics/targeted radiotherapies/small molecules preferred.
Knowledge & Skills
- Strong knowledge of clinical pharmacology/pharmacometrics and quantitative decision-making.
- Proven leadership/project management; excellent communication of complex quantitative results.
Compensation
- Washington State Pay Range: $288,030–$353,637 USD.
- Senior Director, Pharmacometrics to lead model-informed drug development strategies across Immunome’s targeted oncology portfolio, supporting pharmacometric analyses for clinical development decisions, dose selection/optimization, regulatory submissions, and product labeling.
Responsibilities
- Develop and implement pharmacometrics strategies aligned with program objectives, clinical pharmacology plans, and regulatory expectations.
- Lead dose selection/optimization, exposure-response assessment, and model-informed decision-making.
- Build standards for modeling, simulation, documentation, and cross-functional integration.
- Lead population PK/PK-PD/exposure-response/disease progression and model-based meta-analysis strategies for development and registration.
- Apply fit-for-purpose PBPK/QSP/translational modeling or simulation for first-in-human, dose escalation/expansion, special populations, DDI risk, and lifecycle development.
- Oversee analysis plans, model development, simulations, QC, and interpretation for scientific rigor and regulatory readiness.
- Partner cross-functionally to integrate pharmacometrics deliverables into study plans and timelines; advise on PK/PD sampling and statistical/data standards.
- Author/review pharmacometrics components of clinical pharmacology plans, analysis plans, reports, investigator brochures, CSRs, and regulatory submissions.
- Lead IND/NDA/BLA contributions, briefing book inputs, health authority responses, and labeling discussions aligned with FDA/EMA/ICH/global expectations.
- Identify and manage external pharmacometrics vendors/CROs; oversee scope, budget, timeline, technical review, and QC.
- Lead/mentor pharmacometricians; communicate findings to senior leaders and regulatory audiences.
Qualifications
- Ph.D. (12+ yrs), M.S. (15+ yrs), or B.S. (18+ yrs) in a relevant quantitative discipline (pharmacometrics/clinical pharmacology/statistics/etc.).
- Track record leading pharmacometrics strategy/execution across multiple clinical-stage programs and regulatory submission support.
- Deep expertise in population PK, PK/PD, exposure-response, simulation, dose optimization, and model-informed development.
- Global regulatory filing experience (IND/NDA/BLA, briefing book, labeling, health authority responses).
- Hands-on tools: NONMEM, Monolix, Phoenix, R, SAS, Python, MATLAB, Simcyp, GastroPlus (or similar).
- Oncology experience required; ADCs/biologics/targeted radiotherapies/small molecules preferred.
Knowledge & Skills
- Strong knowledge of clinical pharmacology/pharmacometrics and quantitative decision-making.
- Proven leadership/project management; excellent communication of complex quantitative results.
Compensation
- Washington State Pay Range: $288,030–$353,637 USD.