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Bothell, Washington, United States
Posted · 20.09.2026
Greenhouse (US)

# Senior Director, Pharmacometrics

Immunome, Inc.

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Position Overview Immunome is&nbsp;seeking&nbsp;a highly experienced and strategic&nbsp;Senior Director,&nbsp;Pharmacometrics&nbsp;to lead model-informed drug development strategies across Immunome’s targeted oncology portfolio. This role will&nbsp;be responsible for&nbsp;the design, execution, interpretation, and communication of&nbsp;pharmacometric&nbsp;analyses that support clinical development decisions, dose selection and optimization, regulatory submissions, and product labeling.&nbsp; The successful candidate will bring deep technical&nbsp;expertise&nbsp;in population PK, PK/PD, exposure-response, simulation, and fit-for-purpose application of PBPK, QSP, or other quantitative modeling approaches. This position offers a highly visible leadership opportunity to shape Immunome’s pharmacometrics strategy, influence program and portfolio decisions, and advance innovative oncology therapeutics from early clinical development through registration and lifecycle management.&nbsp; Responsibilities Strategic Leadership&nbsp; Develop and implement pharmacometrics strategies across clinical development programs, ensuring quantitative approaches are aligned with program&nbsp;objectives, clinical pharmacology plans, and regulatory expectations.&nbsp; Serve as the pharmacometrics strategy lead for assigned programs, providing scientific leadership for dose selection, dose optimization, exposure-response assessment, and model-informed decision-making.&nbsp; Contribute to the long-term vision for Immunome’s quantitative clinical pharmacology capabilities, including standards for modeling, simulation, documentation, and cross-functional integration.&nbsp; &nbsp; Modeling, Simulation, and Quantitative Strategy&nbsp; Lead the development and execution of population PK, PK/PD, exposure-response, disease progression, and model-based meta-analysis strategies to support clinical development and registration.&nbsp; Apply fit-for-purpose PBPK, QSP, translational modeling, or simulation approaches to inform first-in-human strategy, dose escalation, dose expansion, special populations, drug-drug interaction risk, and lifecycle development.&nbsp; Oversee analysis plans, model development, simulations, quality control, and interpretation of&nbsp;pharmacometric&nbsp;outputs to ensure scientific rigor, reproducibility, and regulatory readiness.&nbsp; &nbsp; Program Oversight and Execution&nbsp; Partner with Clinical Pharmacology, Clinical Development, Biostatistics,&nbsp;ADME,&nbsp;Translational Science,&nbsp;Bioanalytical, Regulatory, Clinical Operations, Data Management, and Medical Writing to integrate pharmacometrics deliverables into development plans and study timelines.&nbsp; Provide input into clinical protocols, sparse and intensive PK/PD sampling strategies, statistical analysis plans, data standards, and integrated evidence generation plans.&nbsp; Serve as the primary pharmacometrics representative on cross-functional program teams and governance forums, translating quantitative findings into clear development recommendations.&nbsp; &nbsp; Regulatory and Documentation Support&nbsp; Author, review, and provide strategic oversight for pharmacometrics components of clinical pharmacology plans, modeling and simulation analysis plans, reports, investigator brochures, clinical study reports, and regulatory submissions.&nbsp; Lead pharmacometrics contributions to INDs, NDAs, BLAs, briefing books, responses to health authority questions, and labeling discussions.&nbsp; Ensure pharmacometrics activities are conducted in alignment with applicable FDA, EMA, ICH, and global regulatory expectations for model-informed drug development, population PK, and exposure-response analyses.&nbsp; &nbsp; Vendor and Partner Management&nbsp; Identify, qualify, and manage external pharmacometrics vendors, consultants, and CRO partners to ensure high-quality,&nbsp;timely, and scientifically robust deliverables.&nbsp; Maintain oversight of outsourced analyses, including scope definition, budget planning, timeline management, technical review, and quality control of modeling and simulation outputs.&nbsp; &nbsp; Leadership and Collaboration&nbsp; Lead and mentor pharmacometricians and quantitative scientists, fostering an environment of scientific excellence, innovation, accountability, and collaboration.&nbsp; Communicate complex modeling results and development&nbsp;implications clearly&nbsp;to senior leaders, cross-functional stakeholders, external collaborators, and regulatory audiences.&nbsp; Collaborate closely with Clinical Pharmacology, Clinical Development, Regulatory,&nbsp;ADME, Bioanalytical,&nbsp;Translational Science&nbsp;and Biometrics functions to align quantitative strategies with broader development&nbsp;objectives.&nbsp; &nbsp; Qualifications Ph.D. in Pharmacometrics, Clinical Pharmacology, Pharmaceutical Sciences, Statistics, Bioengineering, Applied Mathematics, or related quantitative discipline with 12+ years of relevant experience in the biopharmaceutical industry;&nbsp;M.S. with 15+ years; or B.S. with 18+ years of relevant experience in clinical pharmacology, pharmacometrics, quantitative pharmacology, or related drug development functions, or equivalent experience.&nbsp; Demonstrated&nbsp;track record&nbsp;leading pharmacometrics strategy and execution across multiple clinical-stage programs, including early development, late-stage development, and regulatory submission support.&nbsp; Deep&nbsp;expertise&nbsp;in population PK, PK/PD, exposure-response, simulation, dose optimization, and model-informed drug development.&nbsp; Experience supporting global regulatory filings and interactions, including IND, NDA, BLA, briefing book, labeling, and health authority response activities.&nbsp; Hands-on experience with pharmacometrics and quantitative analysis tools such as NONMEM,&nbsp;Monolix, Phoenix, R, SAS, Python, MATLAB,&nbsp;Simcyp,&nbsp;GastroPlus, or related platforms.&nbsp; Experience managing external pharmacometrics vendors, CROs, consultants, and cross-functional deliverables.&nbsp; Oncology drug development experience&nbsp;required; experience with ADCs, biologics, targeted radiotherapies, or small molecules preferred.&nbsp; &nbsp; Knowledge and Skills In-depth knowledge of clinical pharmacology, pharmacometrics, population PK, exposure-response, PBPK, QSP, translational modeling, and quantitative decision-making across drug development.&nbsp; Strong understanding of global regulatory expectations for model-informed drug development, dose justification, labeling support, and submission-quality pharmacometrics documentation.&nbsp; Proven leadership and project management skills across multiple programs, vendors, timelines, and stakeholders.&nbsp; Excellent communication skills — capable of clearly conveying complex quantitative analyses, assumptions, limitations, and recommendations to diverse technical and non-technical audiences.&nbsp; Demonstrated success influencing cross-functional teams and driving data-informed decisions in a matrixed biotech or pharmaceutical environment.&nbsp; Exceptional organizational, analytical, and problem-solving skills with a commitment to scientific rigor, quality, and reproducibility.&nbsp; Washington State Pay Range$288,030&mdash;$353,637 USDE/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

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