Associate Director/Director, Clinical Pharmacology and Pharmacometrics

Immunome, Inc.•Bothell, WA

22h•$193,770 - $244,504

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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets. Position Overview The Associate Director or Director, Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology, clinical pharmacology strategy, and oncology drug development. This role reports to the SD or ED of Clinical Pharmacology and Pharmacometrics.

Requirements

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.
Extensive experience managing relationships with clinical pharmacology vendors.
Excellent written/oral communication, interpersonal and problem-solving skills.
Experience managing clinical pharmacology related data transfers, analysis, reporting and related timelines.
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 successful submission of at least one global filing for approval (NDA/BLA).
Experience of development of anti-cancer agents, preferably ADCs and/or RLTs.
Experience in oncology drug development with small a 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 interacting with global health authorities on optimal dosage design and clinical pharmacology strategy.

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.

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