Associate Director, Clinical Operations

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:

TheDirector,Clinical Operationsprovides strategic and operational leadership for clinical trials and programsand isaccountablefor theiron-time and on-budget delivery.Therole willoversees Clinical Trial Managers and study teams,ensures high-quality execution across multiple trials, and contributes to program-level strategyaccording to andin 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 stateor regionalregulations.

Essential duties and responsibilities include the following.Other duties may be assigned.

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Develop clinical operational strategy andoversee globalclinicalstudyteams,CROsandvendorstoensurethatthestudy(ies)arecompletedontime,withinbudget,andincompliancewithRayzeBioSOPsand in adherence withICH/GCPguidelines

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Oversee all operational aspects of clinical trial execution including planningand feasibility, start-up, conduct, close-out, and reporting

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Identifyand evaluate operational risks and mitigations at a program level

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Contribute to clinical development plansand clinical protocol design

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Leadsthecross-functionalstudyexecutionteamin achieving the study goals and deliverables

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Proactivelyescalatesissuestokeyinternalstakeholderstoensuretimelyresolution of issues

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Perform oversight review and quality control of CRO and vendor scope of activities, ensuringcompliancetokey performance metrics andoverall inspection readiness

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SupportCROand vendorgovernancemeetingsandcontributestogovernance structure and plans, performancedataand escalations study/program risks, as needed

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Drive continuous process improvement and implementation of best practices

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Ensure global inspection readiness and lead interactions during regulatory inspections

- Performsotherrelateddutiesasassigned

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Leverage AI tools to enhance individual productivity and quality of work

- Up to 20%travelrequired

Education and Experience

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BA/BS degree, scientific or healthcare discipline preferred

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Minimum6-8yearsrelevant clinical operations experience in pharmaceutical/biotech industry, with at least3years in oncology trials

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Prior people management or leadership experience preferred

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Prior experience in development programs withradiopharmaceuticals,theranosticsand/orcompanion diagnostics highly desirable

Skills and Qualifications

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Independentprofessionalwhoproactivelycommunicatesfrequentlyandeffectively.

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Strong leadership and project management skills across complexprograms andcross-functionalteamsand able to drive decision making

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Strong financial and resource management skills

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

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Detailand action-oriented, organized and committed to quality and consistency.

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

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Expertisein Microsoft Project andSmartSheetsdesired.

WorkEnvironment

The noise level in theworkenvironment 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 - U