VP, Clinical Operations

Company: Fusion Pharmaceuticals
Location: Chelsea
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. The Vice President of Clinical Operations is a leadership role accountable for the establishment of clinical operations strategy, planning, oversight, and successful delivery for multiple clinical programs. This position requires a self-directed, dynamic individual with the ability to execute and advance treatment options in oncology. The ideal candidate will have strong collaborative, management and communication skills. In addition, the VP will be a hands-on leader willing to roll-up their sleeves to ensure the highest quality of work output. Reporting to the Executive Vice President, Clinical Development, your core duties and responsibilities will include, but are not limited to:Responsibilities:Responsible for the leadership, oversight and execution of clinical trials ensuring they are completed according to timelines, budgets and regulatory/corporate quality standardsServe as a functional leader, line manager and subject matter expert for Clinical Operations team and play a key role in mentoring teamWork collaboratively with other senior/functional leaders in the achievement of departmental and corporate objectives and initiativesProactively seek to improve the efficiency, effectiveness and quality of Fusion's clinical trial activities ensuring all clinical studies are conducted in accordance with company SOPs, GCPs and ICH guidelines Lead the development and/or review of specific study documents (informed consent forms, study guidelines, operation manuals & training materials)Provide leadership in development of the clinical components of regulatory submissions including clinical trial protocols Lead and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sitesDevelops clinical operations strategies including formulation of development budgets and resourcing plan; oversee and manage clinical development program budgetEnsure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing program specific goals, tracking metrics, producing and presenting summary reportsPrepare and present clinical development trial updates to project teams and management and review any potential issues or recommendationsEnsures the identification, recruitment and selection of appropriate clinical investigators and contract research organizations as well as the appropriate negotiation of contracts and budgetsEvaluate vendor, site and study performance metrics against agreed upon budget, deliverables and timelines; provides corrective action plans and implements risk mitigation strategies as appropriateQualifications:BA/BS in a scientific field of study with 10-15 years of relevant experience working in in the pharmaceutical/ biotech industryOncology Experience RequiredExperience in managing multiple projects and priorities.In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledgeExperience in developing Clinical Operations SOPs and metricsProven leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environmentStrong collaboration and team-working, communication and organizational skills requiredStrong problem solving and analytical skills necessaryAbility to prioritize and manage time demand, incomplete information, and unexpected eventsWilling to travel domestically and internationallyAll 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-96c7d166-5da3-4c2d-8326-e77766416033

Keywords: Fusion Pharmaceuticals, Chelsea , VP, Clinical Operations, Healthcare , Chelsea, Massachusetts