Associate Director, Clinical Operations

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

• 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

• Independent professional who proactively communicates frequently and effectively.

• Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making

• Strong financial and resource management skills

• Deep knowledge of global clinical trial operations and regulations (ICH-GCP)

• Detail and action-o riented, organized and committed to quality and consistency .

• Ability to work in a dynamic environment with a high degree of flexibility .

• Expertise in Microsoft Project and SmartSheets desired .