Senior Director, Pharmacometrics
Immunome, Inc.
August 29, 2026
On-site
Bothell, WA
$288,030 - $353,637 USD yearly
Clinical Research and Development
Responsibilities:
- Develop and implement pharmacometrics strategies across clinical development programs; lead dose selection/optimization and exposure-response assessment using model-informed decision-making.
- Lead development of population PK/PK-PD/exposure-response/disease progression and model-based meta-analysis; apply fit-for-purpose PBPK/QSP/translational modeling to support first-in-human, dose escalation/expansion, special populations, DDI risk, and lifecycle development.
- Oversee analysis plans, model development, simulations, QC, and interpretation to ensure scientific rigor, reproducibility, and regulatory readiness.
- Integrate pharmacometrics deliverables with Clinical Pharmacology, Clinical Development, Biostatistics, ADME, Translational Science, Bioanalytical, Regulatory, Clinical Ops, Data Management, and Medical Writing; input into protocols and sampling strategies; translate findings into clear recommendations.
- Author/review pharmacometrics components of clinical pharmacology plans, modeling/simulation plans, reports, investigator brochures, CSRs, and regulatory submissions (IND/NDA/BLA, briefing books, health-authority responses, labeling discussions), aligned with FDA/EMA/ICH/global expectations.
- Identify/qualify/manage vendors/CROs; lead review/oversight of outsourced modeling/simulation outputs.
- Lead/mentor pharmacometricians; communicate complex results to senior leaders and regulatory audiences.
Qualifications:
- Ph.D. with 12+ years (or M.S. 15+ years / B.S. 18+ years) in pharmacometrics/clinical pharmacology/pharmaceutical sciences/stats/applied math or related.
- 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, model-informed drug 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.
Skills/Knowledge:
- Strong leadership, project management, and cross-functional influence; excellent communication; strong organizational/analytical/problem-solving skills.
Pay range: $288,030–$353,637 (Washington State).
- Develop and implement pharmacometrics strategies across clinical development programs; lead dose selection/optimization and exposure-response assessment using model-informed decision-making.
- Lead development of population PK/PK-PD/exposure-response/disease progression and model-based meta-analysis; apply fit-for-purpose PBPK/QSP/translational modeling to support first-in-human, dose escalation/expansion, special populations, DDI risk, and lifecycle development.
- Oversee analysis plans, model development, simulations, QC, and interpretation to ensure scientific rigor, reproducibility, and regulatory readiness.
- Integrate pharmacometrics deliverables with Clinical Pharmacology, Clinical Development, Biostatistics, ADME, Translational Science, Bioanalytical, Regulatory, Clinical Ops, Data Management, and Medical Writing; input into protocols and sampling strategies; translate findings into clear recommendations.
- Author/review pharmacometrics components of clinical pharmacology plans, modeling/simulation plans, reports, investigator brochures, CSRs, and regulatory submissions (IND/NDA/BLA, briefing books, health-authority responses, labeling discussions), aligned with FDA/EMA/ICH/global expectations.
- Identify/qualify/manage vendors/CROs; lead review/oversight of outsourced modeling/simulation outputs.
- Lead/mentor pharmacometricians; communicate complex results to senior leaders and regulatory audiences.
Qualifications:
- Ph.D. with 12+ years (or M.S. 15+ years / B.S. 18+ years) in pharmacometrics/clinical pharmacology/pharmaceutical sciences/stats/applied math or related.
- 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, model-informed drug 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.
Skills/Knowledge:
- Strong leadership, project management, and cross-functional influence; excellent communication; strong organizational/analytical/problem-solving skills.
Pay range: $288,030–$353,637 (Washington State).