Scientist II, Clinical Pharmacology & Pharmacometrics

Immunome; Bothell (WA); On-site; USD 110,000 - 170,000; Full time

Job summary

ISoP in Bothell, WA seeks a Scientist II in Clinical Pharmacology and Pharmacometrics to lead quantitative pharmacology strategy for oncology programs. The role entails applying PK/PD, PBPK and modeling to inform dose selection and to inform decisions across development stages, while coordinating with CROs and internal teams to advance assets toward regulatory filing.

This position requires a PhD/PharmD and a track record in modeling, translational pharmacology and collaboration with regulatory

Qualifications

• Ph.D. or PharmD in clinical pharmacology, pharmacometrics or related field.
• 0–2+ years in regulated bioanalytical environments with modalities incl. small molecule, large molecule and ADCs.
• Experience with noncompartmental and PBPK analyses and PK/PM modeling tools (WINNONLIN, NONMEM, MONOLIX).
• Proficiency in R, R-shiny, SAS, MATLAB, NONMEM, MONOLIX, PBPK tools and integration with oncology programs.
• Familiarity with global regulatory guidance for clinical pharmacology.
• Experience in anti-cancer agent development, preferably ADCs or RLTs.

Responsibilities

• Formulate and deliver CP&MS strategy for late-stage and early development assets.
• Apply PK/PD, PBPK and M&S approaches to characterize drug exposure and inform dose selection and go/no-go decisions.
• Work with preclinical and clinical CROs and internal scientists to conduct and monitor clinical pharmacology studies, maintain study records and ensure study completion.
• Drive program strategy, study design, protocol preparation, execution, data review/analysis and regulatory document preparation.

Skills

PK/PD modeling

PBPK modeling

M&S for oncology

Team collaboration

Regulatory strategy understanding

Education

Ph.D. or PharmD in clinical pharmacology/pharmacometrics or related

Tools

WINNONLIN

NONMEM

MONOLIX

R

R-shiny

SAS

MATLAB

PBPK tools (GastroPlus/Simcyp)

Job description

Position Overview

The Scientist II, 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).
• 0-2+ years' experience in pharmaceutical/biotechnology industry in 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.

Knowledge and Skills

• Excellent written/oral communication, interpersonal and problem-solving skills.
• 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.
• 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.