Immunome, Inc.
Senior Director, Pharmacometrics
Bothell, Washington, United States · Director
Sponsorship not specifiedDetected 26 days ago
StatisticsPharmacologyFDA RegulatoryLeadershipCommunicationBiostatistics
About the role
- 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.
Responsibilities
- 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.
- 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.
- Regulatory and Documentation Support
- Vendor and Partner Management &nb
- Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies.
- 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.
Benefits
- Contribute to the long-term vision for Immunome's quantitative clinical pharmacology capabilities, including standards for modeling, simulation, documentation, and cross-functional integration.
- Lead pharmacometrics contributions to INDs, NDAs, BLAs, briefing books, responses to health authority questions, and labeling discussions.
Company info
- 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.
- We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Apply directly at Immunome, Inc. →Create a free account for alerts like thisView Immunome, Inc. immigration profile
This listing is sourced directly from Immunome, Inc.'s careers page and normalized into a canonical job model.