Principal Scientist, Clinical Pharmacology & Pharmacometrics at Immunome, Inc.

Bothell, Washington, United StatesFull-timeDevelopmentPosted 17 days ago

About the Role

<div class="content-intro">Company Overview <div class="x_elementToProof" data-olk-copy-source="MessageBody"> <div data-olk-copy-source="MessageBody">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.</div> </div></div>Position Overview The Principal Scientist, Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology, clinical pharmacology strategy, and oncology drug development.    Responsibilities <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Formulate and deliver CP&MS strategy for late-stage and early preclinical/clinical development assets.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">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.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">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.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Contribute and drive program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.  </li> </ul>    Qualifications <ul> <li data-leveltext="·" data-font="Symbol" data-listid="27" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Ph.D. or PharmD in a relevant scientific discipline (clinical pharmacology, pharmacometrics or closely related scientific discipline)  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="28" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="29" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Experience in noncompartmental and PBPK analyses and pharmacometric modeling and simulation oversight including use of WINNONLIN, NONMEM, MONOLIX or similar statistical modeling software  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="30" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="31" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Familiarity with current global clinical pharmacology and pharmacometrics regulatory guidance.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="32" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Experience in development of anti-cancer agents, preferably ADCs and/or RLTs.  </li> </ul>    Knowledge and Skills <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Excellent written/oral communication, interpersonal and problem-solving skills.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">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.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Ability to deliver integrated clinical pharmacology roadmap to registration and new product label.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Can manage multiple project related workstreams simultaneously under tight timelines collaboratively.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Experience managing clinical pharmacology related data transfers, analysis, reporting, and related timelines.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">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).  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1">Knowledge of regulatory requirements governing drug development.  </li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="26" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Resourcefulness, pragmatism, creativity, and an independent work ethic.  </li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">Washington State Pay Range</div><div class="pay-range">$186,120—$211,797 USD</div></div></div><div class="content-conclusion">E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: <a href="https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk" target="_blank">E-Verify Participation Poster</a> | <a href="https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e" target="_blank">Right to Work Poster (English)</a> | <a href="https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u" target="_blank">Right to Work Poster (Spanish)</a>.</div>

About the Role

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