Principal Scientist, Clinical Pharmacology & Pharmacometrics

About the role

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. The Principal Scientist, 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)
• 2-5 years' experience in pharmaceutical/biotechnology industry in a 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 WINNON