Associate Director, Clinical Operations
PharmaBiotechCROMedTechClinical ResearchRegulatory AffairsQuality Assurancegcpemafdacroraveinform
Job description
Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ The Director , Clinical Operations provides strategic and operational leadership for clinical trials and programs and is accountable for their on-time and on-budget delivery . The role will oversees Clinical Trial Managers and study teams, ensures high-quality execution across multiple trials, and contributes to program-level strategy according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state or regional regulations . Essential duties and responsibilities include the following . Other duties may be assigned. Develop clinical operational strategy and oversee global clinical study teams, CROs and vendors to ensure that the study( ies ) are completed on time, within budget, and in compliance with RayzeBio SOPs and in adherence with ICH/GCP guidelines Oversee all operational aspects of clinical trial execution including planning and feasibility , start-up, conduct, close-out, and reporting Identify and evaluate operational risks and mitigations at a program level Contribute to clinical development plans and clinical protocol design Leads the cross-functional study execution team in achieving the study goals and deliverables P roactively escalates issues to key internal stakeholders to ensure timely resolution of issues P erform oversight review and quality control of CRO and vendor scope of activities, ensuring compliance to key performance metrics and overall inspection readiness Support CRO and vendor governance meetings and contributes to governance structure and plans , performance data and escalations study/program risks, as needed Drive continuous process improvement and implementation of best practices Ensure global inspection readiness and lead interactions during regulatory inspections Performs other related duties as assigned Leverage AI tools to enhance individual productivity and quality of work Up to 20% travel required Education and Experience BA/BS degree, scientific or healthcare discipline preferred Minimum 6-8 years relevant clinical operations experience in pharmaceutical/biotech industry , with at least 3 years in oncology trials Prior people management or leadership experience preferred Prior experience in development programs with radiopharmaceuticals, theranostics and/or companion diagnostics highly desirable Skills and Qualifications <
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