助理总监,临床运营
Associate Director, Clinical Operations
BMS的工作环境
在RayzeBio,每一天都是激发有意义改变的机会。作为百时美施贵宝的全资子公司,RayzeBio将新兴生物科技的敏捷和开拓精神与肿瘤学领域领先创新者的全球专业知识和资源相结合。我们的使命是开发变革性的放射性药物疗法,为癌症患者带来新的希望。在这里,你将加入一个跨学科的团队,你的想法受到重视,你的专业技能得到提升,协作是我们一切工作的核心。从第一天起,你就能立即产生影响——对我们的科学、对我们的团队,最重要的是,对患者。了解更多关于RayzeBio的信息:
临床运营总监负责临床试验和项目的战略和运营管理,并对按时按预算完成负责。该职位将监督临床试验经理和研究团队,确保在多个试验中高质量执行,并根据公司和项目标准操作流程(SOP)、良好临床实践(GCP)/国际协调会议(ICH)指南以及其他适用的联邦(FDA)和州或地区法规,参与项目层面的战略制定。
主要职责和责任包括以下内容。其他职责可能被指派。
- 制定临床运营策略,监督全球临床研究团队、CRO和供应商,确保研究按时、按预算、符合RayzeBio SOP,并遵守ICH/GCP指南
- 监督临床试验执行的所有运营方面,包括计划和可行性、启动、实施、结题和报告
- 在项目层面识别并评估运营风险及缓解措施
- 参与临床开发计划和临床方案设计
- 领导跨职能研究执行团队以实现研究目标和交付成果
- 主动向关键内部利益相关者汇报问题,确保问题及时解决
- 对CRO和供应商的活动范围进行监督审查和质量控制,确保符合关键绩效指标和整体检查准备状态
- 支持CRO和供应商治理会议,参与治理结构和计划,根据需要提供表现数据和研究/项目风险的上报
- 推动持续流程改进和最佳实践的实施
- 确保全球检查准备状态,并领导内部审计工作
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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.
- Develop clinical operational strategy andoversee globalclinicalstudyteams,CROsandvendorstoensurethatthestudy(ies)arecompletedontime,withinbudget,andincompliancewithRayzeBioSOPsand in adherence withICH/GCPguidelines
- Oversee all operational aspects of clinical trial execution including planningand feasibility, start-up, conduct, close-out, and reporting
- Identifyand evaluate operational risks and mitigations at a program level
- Contribute to clinical development plansand clinical protocol design
- Leadsthecross-functionalstudyexecutionteamin achieving the study goals and deliverables
- Proactivelyescalatesissuestokeyinternalstakeholderstoensuretimelyresolution of issues
- Perform oversight review and quality control of CRO and vendor scope of activities, ensuringcompliancetokey performance metrics andoverall inspection readiness
- SupportCROand vendorgovernancemeetingsandcontributestogovernance structure and plans, performancedataand 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
- Performsotherrelateddutiesasassigned
- Leverage AI tools to enhance individual productivity and quality of work
- Up to 20%travelrequired
Education and Experience
- BA/BS degree, scientific or healthcare discipline preferred
- Minimum6-8yearsrelevant clinical operations experience in pharmaceutical/biotech industry, with at least3years in oncology trials
- Prior people management or leadership experience preferred
- Prior experience in development programs withradiopharmaceuticals,theranosticsand/orcompanion diagnostics highly desirable
Skills and Qualifications
- Independentprofessionalwhoproactivelycommunicatesfrequentlyandeffectively.
- Strong leadership and project management skills across complexprograms andcross-functionalteamsand able to drive decision making
- Strong financial and resource management skills
- Deep knowledge of global clinical trial operations and regulations (ICH-GCP)
- Detailand action-oriented, organized and committed to quality and consistency.
- Ability to work in a dynamic environment with a high degree of flexibility.
- 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 - United States - US: $173,217 - $209,899
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at
RayzeBio and Bristol Myers Squibb
RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
Supporting People with Disabilities
BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1606173 : Associate Director, Clinical OperationsOriginally posted on Himalayas