Senior Director, Pharmacometrics
Immunome, Inc.
August 07, 2026
Remote friendly (Bothell, WA)
United States
$288,030 - $353,637 USD yearly
Clinical Research and Development
Responsibilities
- Develop and implement pharmacometrics strategies aligned to program objectives, clinical pharmacology plans, and regulatory expectations.
- Lead pharmacometrics for assigned programs, including dose selection/optimization and exposure-response assessment for model-informed decisions.
- Lead population PK, PK/PD, exposure-response, disease progression, and model-based meta-analysis to support clinical development and registration.
- Apply fit-for-purpose PBPK/QSP/translational and simulation approaches for first-in-human strategy, dose escalation/expansion, special populations, DDI risk, and lifecycle development.
- Oversee analysis plans, model development, simulations, quality control, and interpretation for rigor, reproducibility, and regulatory readiness.
- Partner cross-functionally to integrate pharmacometrics deliverables into development plans; provide input to protocols, PK/PD sampling, SAPs, data standards, and integrated evidence plans.
- Author/review pharmacometrics components of clinical pharmacology plans, analysis plans, reports, IBs, CSRs, and regulatory submissions (IND/NDA/BLA, briefing books, health authority Q&A, labeling).
- Manage/qualify external pharmacometrics vendors/CROs and oversee outsourced scope, budgets, timelines, technical review, and QC.
- Lead/mentor pharmacometricians and clearly communicate modeling results to leaders and regulators.
Qualifications/Skills
- Ph.D. (or MS/BS with commensurate years): 12+ years (Ph.D.), 15+ years (MS), or 18+ years (BS) in clinical pharmacology/pharmacometrics/quantitative drug development.
- Proven track record leading pharmacometrics strategy/execution across multiple clinical-stage programs.
- Deep expertise in population PK, PK/PD, exposure-response, simulation, dose optimization, and model-informed drug development.
- Global regulatory filing experience (IND/NDA/BLA, briefing books, 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.
Washington State Pay Range
- $288,030 - $353,637 USD
- Develop and implement pharmacometrics strategies aligned to program objectives, clinical pharmacology plans, and regulatory expectations.
- Lead pharmacometrics for assigned programs, including dose selection/optimization and exposure-response assessment for model-informed decisions.
- Lead population PK, PK/PD, exposure-response, disease progression, and model-based meta-analysis to support clinical development and registration.
- Apply fit-for-purpose PBPK/QSP/translational and simulation approaches for first-in-human strategy, dose escalation/expansion, special populations, DDI risk, and lifecycle development.
- Oversee analysis plans, model development, simulations, quality control, and interpretation for rigor, reproducibility, and regulatory readiness.
- Partner cross-functionally to integrate pharmacometrics deliverables into development plans; provide input to protocols, PK/PD sampling, SAPs, data standards, and integrated evidence plans.
- Author/review pharmacometrics components of clinical pharmacology plans, analysis plans, reports, IBs, CSRs, and regulatory submissions (IND/NDA/BLA, briefing books, health authority Q&A, labeling).
- Manage/qualify external pharmacometrics vendors/CROs and oversee outsourced scope, budgets, timelines, technical review, and QC.
- Lead/mentor pharmacometricians and clearly communicate modeling results to leaders and regulators.
Qualifications/Skills
- Ph.D. (or MS/BS with commensurate years): 12+ years (Ph.D.), 15+ years (MS), or 18+ years (BS) in clinical pharmacology/pharmacometrics/quantitative drug development.
- Proven track record leading pharmacometrics strategy/execution across multiple clinical-stage programs.
- Deep expertise in population PK, PK/PD, exposure-response, simulation, dose optimization, and model-informed drug development.
- Global regulatory filing experience (IND/NDA/BLA, briefing books, 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.
Washington State Pay Range
- $288,030 - $353,637 USD