Principal Scientist, Clinical Pharmacology & Pharmacometrics

Immunome•Bothell, WA

About The Position

The Principal Scientist, Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology, clinical pharmacology strategy, and oncology drug development. This role involves formulating and delivering CP&MS strategy for late-stage and early preclinical/clinical development assets. The scientist will 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. Responsibilities include working 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. The role also involves contributing to and driving program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation, and regulatory document preparation.

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.