About this role
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
Proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
Perform 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
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-oriented, 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.
Work Environment
The noise level in the work environment is usually moderate.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Remote - United States - US: $173,217 - $209,899