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Associate Director/Director, PK/PD/PMX

Company: Fusion Pharmaceuticals
Location: Somerville
Posted on: September 23, 2022

Job Description:

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear linker technology, and leveraging the Company's actinium supply and manufacturing expertise, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs), the first of which is currently in IND enabling studies, and explore up to five combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R.The Associate Director/Director, PK/PD/PMX will be responsible for leading efforts to analyze, interpret, and model pharmacokinetic/pharmacodynamic, safety, efficacy, and dosimetry data to support preclinical and clinical program teams. This role will be highly crossfunctional in nature 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 determination of therapeutic index. Successful candidates will have demonstrated the potential to design and execute fit-for-purpose PK/PD analysis/modeling efforts with impact on significant decisions and outcomes on discovery/development teams.Responsibilities:The Associate Director/Director, PK/PD/PMX will provide PK/PD/Pharmacometric and scientific leadership through analysis and interpretation of PK/PD and dosimetry data in support of preclinical, translational, and clinical studies and programsLead efforts to translate preclinical data to the clinical setting by integrating data from the literature and crossfunctional colleagues to project PK/PD and safety properties of targeted alpha therapies in humansInterpret, analyze, and model quantitative data to support the selection of targets, molecules, dose levels or regimens, patient populations, and development strategies for novel radiopharmaceuticals Understand and anticipate the high-level issues affecting the drug discovery/development process and help derive effective solutions. Support decision-making and implement solutions through proactive communication and collaboration on cross-functional teams.Plan, develop and execute PK/PD strategy of program and product team as project leaderLead and support the preparation and delivery of relevant portions of Phase I, II, and III study protocols, analysis plans, data interpretation, and study reportsResponsible for 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 FDA, EMA, and PMDA, among other regulatory agencies.Provide coaching and mentoring to other scientists within the department and across the company as well as interact, teach, and collaborate with the broader research communityRepresent the group to increase visibility externally through key publications and active leadership in key scientific organizationsQualifications:PhD in in Computer Science, Mathematics, Engineering, Pharmaceutical Sciences, or a degree in another research area relevant to PK/PD/Pharmacometrics and 5+ years of industry experience. Alternatively, a BS/MS degree and 8+ years of relevant industry experience.Good technical knowledge of PK/PD analysis and pharmacokinetic modeling and experience with PK/PD modeling of biologicsDirect experience in modeling PK/PD data by applying at least one of the following: population PK/PD, physiologically based pharmacokinetic (PBPK) modeling, target-mediated drug disposition (TMDD), or quantitative systems pharmacology (QSP) Ability to lead PK/PD/PMX efforts across multiple programs and modalities and to communicate the results and implications of findings with crossfunctional program teamsExcellent interpersonal skills that lead to successful collaborative working relationships with key colleagues across the organization including clinical, discovery, and managementUnderstanding of the drug discovery and development process and how PK/PD/PMX can inform drug discovery/development and address key questionsDesire to carry out scientific development and research work with a view to publishing collaborativelyStrong customer focus with the ability to have robust discussions with project leaders to ensure that project, scientific and resource demands are aligned. Fusion requires all employees to be current with their COVID vaccination requirements.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Keywords: Fusion Pharmaceuticals, Somerville , Associate Director/Director, PK/PD/PMX, Executive , Somerville, Massachusetts

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