Senior Director, Pharmacometrics

Position Overview

Immunome is seeking a highly experienced and strategic Senior Director, Pharmacometrics to lead model-informed drug development strategies across Immunome’s targeted oncology portfolio.

Responsibilities

• Strategic Leadership
• Develop and implement pharmacometrics strategies across clinical development programs, ensuring quantitative approaches are aligned with program objectives, clinical pharmacology plans, and regulatory expectations.
• 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.
• Contribute to the long-term vision for Immunome’s quantitative clinical pharmacology capabilities, including standards for modeling, simulation, documentation, and cross-functional integration.
• Modeling, Simulation, and Quantitative Strategy
• 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.
• 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.
• Oversee analysis plans, model development, simulations, quality control, and interpretation of pharmacometric outputs to ensure scientific rigor, reproducibility, and regulatory readiness.
• Program Oversight and Execution
• Partner with Clinical Pharmacology, Clinical Development, Biostatistics, ADME, Translational Science, Bioanalytical, Regulatory, Clinical Operations, Data Management, and Medical Writing to integrate pharmacometrics deliverables into development plans and study timelines.
• Provide input into clinical protocols, sparse and intensive PK/PD sampling strategies, statistical analysis plans, data standards, and integrated evidence generation plans.
• Serve as the primary pharmacometrics representative on cross-functional program teams and governance forums, translating quantitative findings into clear development recommendations.
• Regulatory and Documentation Support
• 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.
• Lead pharmacometrics contributions to INDs, NDAs, BLAs, briefing books, responses to health authority questions, and labeling discussions.
• 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.
• Vendor and Partner Management
• Identify, qualify, and manage external pharmacometrics vendors, consultants, and CRO partners to ensure high-quality, timely, and scientifically robust deliverables.
• Maintain oversight of outsourced analyses, including scope definition, budget planning, timeline management, technical review, and quality control of modeling and simulation outputs.
• Leadership and Collaboration
• Lead and mentor pharmacometricians and quantitative scientists, fostering an environment of scientific excellence, innovation, accountability, and collaboration.
• Communicate complex modeling results and development implications clearly to senior leaders, cross-functional stakeholders, external collaborators, and regulatory audiences.
• Collaborate closely with Clinical Pharmacology, Clinical Development, Regulatory, ADME, Bioanalytical, Translational Science and Biometrics functions to align quantitative strategies with broader development objectives.

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; 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.
• Demonstrated track record leading pharmacometrics strategy and execution across multiple clinical-stage programs, including early development, late-stage development, and regulatory submission support.
• Deep expertise in population PK, PK/PD, exposure-response, simulation, dose optimization, and model-informed drug development.
• Experience supporting global regulatory filings and interactions, including IND, NDA, BLA, briefing book, labeling, and health authority response activities.
• Hands-on experience with pharmacometrics and quantitative analysis tools such as NONMEM, Monolix, Phoenix, R, SAS, Python, MATLAB, Simcyp, GastroPlus, or related platforms.
• Experience managing external pharmacometrics vendors, CROs, consultants, and cross-functional deliverables.
• Oncology drug development experience required; experience with ADCs, biologics, targeted radiotherapies, or small molecules preferred.

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.
• Strong understanding of global regulatory expectations for model-informed drug development, dose justification, labeling support, and submission-quality pharmacometrics documentation.
• Proven leadership and project management skills across multiple programs, vendors, timelines, and stakeholders.
• Excellent communication skills — capable of clearly conveying complex quantitative analyses, assumptions, limitations, and recommendations to diverse technical and non-technical audiences.
• Demonstrated success influencing cross-functional teams and driving data-informed decisions in a matrixed biotech or pharmaceutical environment.
• Exceptional organizational, analytical, and problem-solving skills with a commitment to scientific rigor, quality, and reproducibility.

Washington State Pay Range

$288,030 - $353,637 USD

E/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

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