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Clinical Trial Associate

Company: Fusion Pharmaceuticals
Location: Chelsea
Posted on: August 4, 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-1RSummary: In this Clinical Operations role, the Clinical Trial Manager is responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. This position will report and reside in our Boston, MA office.The successful candidate will:Assist with the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and executionManage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with GCP and ICH guidelines.Work closely with the Program Lead to coordinate, track, and manage all logistics in support of the clinical ProgramResponsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the Program Lead and Finance.Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationshipsAssist with authoring of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessaryPartner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trialsLead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as neededAssists with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations.Education and Experience:BA/BS in a scientific field of study with 3-5 years progressive experience in clinical operations.Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.Ability to handle a high volume of highly complex tasks within a given timeline.Ability to lead a cross-functional team in a matrix environmentExperience managing clinical programs, CROs, budgets, and timelines requiredStrong working knowledge of MS Project and developing Gantt chartsExcellent interpersonal and negotiation skillsStrong verbal and written communication and presentation skillsTravel up to 20%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. PDN-96dff5e1-26bd-4f06-8682-8c6303205a8f

Keywords: Fusion Pharmaceuticals, Chelsea , Clinical Trial Associate, Healthcare , Chelsea, Massachusetts

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