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Associate Director, Clinical Operations

Bristol Myers Squibb

RemoteUnited StatesUSD 173k–210kdirectorFull Time
Posted
1 month ago
Source
Himalayas
Field
Operations

Skills

Project ManagementLeadershipSecurityExcelGCPAI

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: 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 Operations Originally posted on Himalayas

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