Immunome, Inc. · 1 day ago
Associate Director/Director, Clinical Pharmacology and Pharmacometrics
Bothell, Washington, United States
Full-time
Onsite
Lead/Staff, Director/Executive
$194K/yr - $245K/yr
4+ years expImmunome is a clinical-stage targeted oncology company committed to developing innovative cancer therapies. The Associate Director or Director of Clinical Pharmacology and Pharmacometrics will focus on oncology quantitative pharmacology, clinical pharmacology strategy, and drug development, overseeing the formulation of strategies and conducting clinical pharmacology studies.
BiopharmaBiotechnologyMedicalPharmaceutical
Responsibilities
Excellent written/oral communication, interpersonal and problem-solving skills
Formulate and deliver CP&MS strategy for late-stage and early preclinical/clinical development assets
Apply pharmacokinetic/pharmacodynamics (PK/PD), physiologic based PK (PBPK) and pharmacometric modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions
Work with preclinical and clinical CROs and company scientists to conduct and monitor clinical pharmacology studies, maintain study records and ensure study completion along program timelines
Contribute and drive program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation
Qualification
Required
Ph.D. in a relevant scientific discipline (clinical pharmacology, pharmacometrics or closely related scientific discipline)
A minimum of 4 years' experience in pharmaceutical/biotechnology industry in regulated bioanalytical environment, preferably with multiple modalities, including small molecule, large molecule and ADC experience
Extensive experience in noncompartmental and PBPK analyses and pharmacometric modeling and simulation oversight including use of WINNONLIN, NONMEM, MONOLIX or similar statistical modeling software
Knowledge of R, R-shiny, SAS, MATLAB, NONMEM, MONOLIX, PBPK (gastroplus or Simcyp) or similar modeling software and substantial experience integrating quantitative clinical pharmacology with oncology drug development strategy
Familiarity with current global clinical pharmacology and pharmacometrics regulatory guidance
Experience in successful submission of at least one global filing for approval (NDA/BLA)
Extensive experience managing relationships with clinical pharmacology vendors
Experience of development of anti-cancer agents, preferably ADCs and/or RLTs
Excellent written/oral communication, interpersonal and problem-solving skills
Experience in oncology drug development with small a large molecule clinical pharmacology strategy
Ability to deliver integrated clinical pharmacology roadmap to registration and new product label
Can manage multiple project related workstreams simultaneously under tight timelines collaboratively
Experience managing clinical pharmacology related data transfers, analysis, reporting and related timelines
Experience interacting with global health authorities on optimal dosage design and clinical pharmacology strategy
Knowledge of regulatory requirements governing drug development
Resourcefulness, pragmatism, creativity and an independent work ethic
Preferred
Experience in translational aspects of drug discovery and development is strongly preferred
Company
Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.
51-200 employees
H1B Sponsorship
Immunome, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Public CompanyTotal Funding
$998.85MKey Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M
Leadership Team
Clay Siegall
President and CEO
Purnanand D. Sarma
President & CEO
Recent News
BioWorld Financial Watch
2025-12-19
thefly.com
2025-12-18
2025-12-17
Company data provided by crunchbase