Scientist II, Clinical Pharmacology & Pharmacometrics

Immunomeinc; Bothell (WA); On-site; USD 140,000 - 172,000; Full time

Job summary

Immunome, Inc. is seeking a Scientist II, Clinical Pharmacology and Pharmacometrics in Washington to lead PK/PD strategy for late-stage and early development assets. You will apply PK/PD, PBPK and modeling to inform dose selection, and collaborate with CROs and internal teams on study design and regulatory documents.

Ideal candidates hold a Ph.D. or PharmD with oncology drug development experience, including ADCs, and strong communication to drive cross-functional programs.

Qualifications

• Ph.D. or PharmD in a relevant scientific discipline (clinical pharmacology, pharmacometrics or closely related scientific discipline).
• 0-2+ years' experience in pharmaceutical/biotechnology industry in regulated bioanalytical environment, preferably with multiple modalities, including small molecule, large molecule and ADC experience.
• 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 development of anti-cancer agents, preferably ADCs and/or RLTs.

Responsibilities

• Formulate and deliver CPMS strategy for late-stage and early preclinical/clinical development assets.
• Apply PK/PD, PBPK and pharmacometric modeling to characterize drug exposure and inform dose selection.
• Collaborate with preclinical and clinical CROs and company scientists to conduct studies and ensure timelines.
• Contribute to program strategy, study design, data review, reports and regulatory documentation.

Skills

Clinical pharmacology

Pharmacokinetics

PBPK

Pharmacometrics

Regulatory strategy

Oncology drug development

Education

Ph.D. or PharmD

Tools

WINNONLIN

NONMEM

MONOLIX

R

R-shiny

SAS

MATLAB

GastroPlus/Simcyp PBPK

Job description

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

The ScientistII, Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology, clinical pharmacology strategy, and oncology drug development.

Responsibilities

• 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.

Qualifications

• Ph.D. or PharmD in a relevant scientific discipline (clinical pharmacology, pharmacometrics or closely related scientific discipline).
• 0-2+ years' experience in pharmaceutical/biotechnology industry in regulated bioanalytical environment, preferably with multiple modalities, including small molecule, large molecule and ADC experience.
• 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 development of anti-cancer agents, preferably ADCs and/or RLTs.

Knowledge and Skills

• Excellent written/oral communication, interpersonal and problem-solving skills.
• Experience in oncology drug development with small and large molecule clinical pharmacology strategy. Experience in translational aspects of drug discovery and development is strongly preferred.
• 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. Effective forms of written and spoken communication is essential (eg clinical pharmacology protocols, pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control).
• Knowledge of regulatory requirements governing drug development.
• Resourcefulness, pragmatism, creativity, and an independent work ethic.

Washington State Pay Range $139,506—$171,900 USD

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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).