Principal Scientist, Clinical Pharmacology & Pharmacometrics
About The Position
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.
Requirements
- 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 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.
- Excellent written/oral communication, interpersonal and problem-solving skills.
- Experience in oncology drug development with small and 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. 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.
Nice To Haves
- Experience in translational aspects of drug discovery and development is strongly preferred.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
