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 seeking a highly experienced and strategic Senior Director, Pharmacometrics to lead model-informed drug development strategies across Immunome’s targeted oncology portfolio. This role will be responsible for the design, execution, interpretation, and communication of pharmacometric analyses that support clinical development decisions, dose selection and optimization, regulatory submissions, and product labeling.
The successful candidate will bring deep technical expertise 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.
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.
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
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).
