Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
Fusion is looking for a creative and motivated Senior Scientist, PK/PD/PMX to join the Pharmacokinetics/Pharmacodynamics and Pharmacometrics team (PK/PD/PMX). PK/PD/PMX scientists analyze, interpret, and model pharmacokinetic/pharmacodynamic, safety, efficacy, and dosimetry data to support preclinical and clinical program teams. This role will be highly cross functional and will seek to synthesize data and information from multiple sources to inform critical decisions and influence decisions related to dose levels and regimens, preclinical to clinical translation, and optimization of therapeutic index.
Responsibilities
- Analyze and interpret PK/PD and dosimetry data to support of preclinical, translational, and clinical studies and programs.
- Translate preclinical data to the clinical setting by integrating data from the literature and cross-functional colleagues to project PK/PD and safety properties of targeted alpha therapies in humans.
- Interpret, analyze, and model quantitative data to support the selection of targets, molecules, dose levels or regimens, patient populations, and development strategies for novel radiopharmaceuticals.
- Support decision-making and implement solutions through proactive communication and collaboration on cross-functional teams.
- Support the preparation and delivery of relevant portions of Phase I, II, and III study protocols, analysis plans, data interpretation, and study reports.
- Support the preparation of relevant INDs, IBs, CTDs and other regulatory documents for development and registration of new drugs and line extensions across multiple geographies. This may involve direct interaction with regulatory agencies.
- Represent the group to increase visibility externally through key publications and active leadership in key scientific organizations.
Qualifications
- PhD or MS in pharmaceutics, pharmacokinetics, pharmacometrics, biostatistics, mathematics, engineering, and related quantitative fields. Applicants holding a PhD should have at least 2 years of post-doctoral or industry experience. MS applicants should have at least 5 years of post graduate experience.
- Strong proficiency in R programming is required
- Experience with a nonlinear mixed-effects modeling software (e.g., Monolix, NONMEM, ADAPT, Phoenix NLME) required
- Experience programming clinical datasets
- Experience in physiologically based pharmacokinetic (PBPK) modeling or quantitative systems pharmacology (QSP)
- Understanding of Bayesian methods and analysis tools (e.g., Stan, JAGS, BUGS, Turing)
- Excellent interpersonal skills that lead to successful collaborative working relationships with key colleagues across the organization including clinical, discovery, and management.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.
