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Director, Clinical Operations

Company: Fusion Pharmaceuticals
Location: Somerville
Posted on: August 4, 2022

Job Description:

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Employing its platform technology, including proprietary Fast-Clear linker, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is growing a pipeline of precision oncology therapies in development, and recently announced a collaboration agreement with AstraZeneca. Reporting into the Executive Vice President, Medical Director and Clinical Development, the Director, Clinical Operations is accountable for the operational strategic planning, oversight and successful delivery for one or more clinical trials/programs. Responsibilities:Provide operational and implementation expertise to Clinical Operations trial team(s) to enable timely progression of clinical development programsFunction as Clinical Operations lead for clinical development program(s) ensuring successful planning, implementation and conduct of all assigned clinical trialsLead selection process of CRO, including generation of Request for Proposal; perform and document Sponsor-level oversight and management of CRO (or collaboration partner) for outsourced activities Work with the cross-functional project team to identify and evaluate issues in the program and suggest and implement solutionsContribute to design, development and review of clinical documents such as protocols, investigator brochures, trial reports and other trial related documentsProvide oversight for development of trial-specific documents (e.g. informed consent forms, study plans/guidelines, operation manuals & training materials)Contribute to and assist with the development of the clinical components of regulatory submissions Maintain oversight and participation in creation/review/training/maintenance of departmental and organization SOPs to ensure compliance Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sitesOversee and manage Clinical Operations program budget Evaluate CRO, site and study performance metrics against agreed upon trial budget, deliverables and timelinesEnsure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing program specific goals, managing timelines, tracking metrics, producing and presenting summary metrics/reportsPrepare and present clinical trial updates to project teams and management and review any potential issues or recommendationsOversee and manage direct reports with regular meetings and mid-year/end-year review processesLead and mentor junior Clinical Operations team membersQualifications:BA/BS in a scientific field of study with a minimum of 8 years of relevant experience working in in the pharmaceutical/ biotech industry, including at least 4 years of clinical trial management experience and full trial life-cycle experience (e.g. start up to closeout)Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning etc.Experience in Oncology highly desiredIn-depth understanding of industry standards and applicable guidelines including FDA regulations and ICH GCP guidelinesExperience in developing Clinical Operations SOPs and trial metricsProven team leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environmentStrong cross-functional collaboration proficiencyExcellent communication and organizational skills Strong problem solving and analytical skills Ability to be flexible, work independently and prioritize workloadWilling to travel domestically and internationallyFusion 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-9672f2d6-5490-4b15-8f86-ede3b964a294

Keywords: Fusion Pharmaceuticals, Somerville , Director, Clinical Operations, Healthcare , Somerville, Massachusetts

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