layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Director, Pharmacometrics at Immunome | LAYIQ

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.
O versee 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.

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.

Senior Director, Pharmacometrics

Employer job description

Responsibilities

Qualifications

Equal opportunity and accommodations

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