Bristol Myers Squibb

Director

• Govern enterprise aseptic and microbial control practices, escalation pathways, cross-functional forums, and decision frameworks
• Provide executive leadership for Quality Council and EAC activities involving sterility assurance and contamination control
• Define enterprise policies, standards, procedures, roadmap, KPIs, and performance monitoring for aseptic operations and microbial control
• Lead enterprise trend detection, signal monitoring, recurring event analysis, and executive risk insights
• Drive cross-site harmonization across the global manufacturing network
• Build and sustain a Community of Practice for sterility assurance and contamination control
• Lead knowledge management initiatives, converting learnings from deviations, audits, and industry trends into prevention actions and training
• Serve as enterprise technical authority for sterility assurance, contamination control, aseptic processing, and microbial risk management
• Provide expertise for technology transfers, PPQ readiness, and commercialization across internal and external manufacturing sites
• Lead oversight of high-risk, systemic, or cross-site contamination events, including impact assessments, root cause investigations, and CAPAs
• Represent BMS in regulatory inspections, agency interactions, and industry forums
• Define and govern environmental monitoring program requirements, standards, sampling plans, frequencies, and personnel sampling
• Modernize environmental monitoring standards in alignment with regulatory expectations and industry best practices
• Monitor CMO performance indicators and risk signals; provide technical input for escalations, deviations, investigations, and technology transfers
• Conduct risk-tiered CMO assessments and implement standardized oversight tools, dashboards, and decision trees
• Govern gowning qualification and sequence standards
• Define personnel, material, and waste flow strategies to minimize contamination risk
• Support facility design reviews and cleanroom classification initiatives

Senior Director, Aseptic Operational Support

Clinical Research

• Serve as the primary site-level contact for internal and external clinical-trial stakeholders
• Conduct site qualification, initiation, routine monitoring, and close-out visits across all trial phases
• Ensure adherence to protocols, BMS SOPs, ICH GCP, and applicable regulations
• Verify clinical-trial data in electronic systems and paper records for accessibility, completeness, and accuracy
• Monitor site compliance, provide training and support, and participate in audits and inspections
• Build relationships with cross-functional teams, vendors, clinical sites, and key stakeholders
• Motivate and influence sites to meet enrollment and retention objectives
• Prepare timely, accurate, concise, professional monitoring and administrative reports
• Assess Investigators and sites for resources and capabilities and identify potential new sites
• Apply targeted, centralized, remote, and risk-based monitoring approaches
• Identify and prioritize site and study risks and support mitigation strategies
• Analyze site data and operational metrics and adjust monitoring strategies based on trends and performance
• Perform Unblinded Site Monitor activities when applicable to protect study blinding
• Review, reconcile, and oversee study drug/IMP and support label translation needs when applicable
• Support regulatory compliance audits, inspections, and corrective and preventive actions
• Support study start-up, submissions, ICF reviews, and site document collection when applicable
• Support access to BMS and vendor systems and maintain internal systems for monitoring activities
• Coordinate site activities related to database locks
• Perform timely site closure activities after required visits and follow-up are completed

Clinical Research Associate

• Serve as the primary site-level contact for internal and external clinical-trial stakeholders
• Oversee the quality, integrity, and compliance of clinical trial sites
• Conduct site qualification, initiation, routine monitoring, and close-out visits across all trial phases
• Verify clinical-trial data in electronic systems and paper records for accessibility, completeness, and accuracy
• Monitor adherence to ICH GCP and local regulations, provide site training and support, and participate in audits and inspections
• Build relationships with cross-functional teams, vendors, clinical sites, and key stakeholders
• Motivate sites to meet enrollment and retention goals
• Prepare and submit monitoring and administrative reports
• Assess investigators and sites for resources and capabilities; identify potential investigators and sites
• Apply targeted, centralized, remote, and risk-based monitoring approaches
• Identify, prioritize, and mitigate site- and study-level risks
• Analyze site data and operational metrics and adjust monitoring strategies
• Perform unblinded site-monitor activities when applicable
• Review, reconcile, and oversee study drug/IMP
• Support regulatory compliance audits, inspections, corrective and preventive actions, and start-up/submission activities
• Support access to BMS and vendor systems and maintain internal systems for site monitoring
• Coordinate site activities related to database locks
• Perform timely site closure activities

Program Manager

• Provide program management support for Translational Development teams across assigned studies, assets, and disease-area workstreams
• Partner with Translational Development Leads, biomarker scientists, clinical teams, laboratory teams, data and analytics teams, operations partners, and vendors to translate project objectives into actionable plans, timelines, deliverables, and follow-up actions
• Coordinate biomarker and translational activities, including assay testing, vendor coordination, data delivery, and documentation of key decisions and outcomes
• Develop, maintain, and communicate integrated timelines for translational activities, including sample logistics, assay development and testing, data transfers, analyses, reporting milestones, and study deliverables
• Facilitate cross-functional meetings by preparing agendas, tracking action items, documenting decisions, and ensuring timely completion of commitments
• Coordinate biospecimen, informed-consent, data-use, and data-transfer activities required to support translational studies and collaborations
• Support management of external laboratories, vendors, and CROs by tracking contracts, statements of work, deliverables, budgets, invoices, timelines, and issue resolution
• Monitor project risks, dependencies, and critical-path activities; develop mitigation plans and escalate issues when appropriate
• Support biomarker budget tracking, forecasting activities, contract management, and purchase-order processes
• Maintain project documentation and collaborative tools, including SharePoint sites, dashboards, trackers, meeting repositories, contact lists, and reporting tools
• Support publication and congress planning activities through tracking abstracts, timelines, authorship coordination, review milestones, and data-readiness requirements
• Identify opportunities to improve operational efficiency, consistency, transparency, and communication across translational project activities

Translational Program Manager – Solid Tumor Translational Development

• Establish and lead an enterprise-wide GxP Quality Center of Excellence covering GCP, GLP, and GVP
• Define and operationalize the GxP CoE strategy, capability model, roadmap, and operating model
• Standardize best practices, tools, frameworks, quality processes, design controls, and lifecycle management across R&D Quality
• Embed proactive, risk-based quality engineering, compliance, Quality by Design, lifecycle management, and continuous improvement
• Partner with R&D, Product Development, Regulatory, Medical, Technology, Operations, and Global Quality stakeholders
• Drive digital transformation, data-driven insights, advanced analytics, AI-enabled solutions, and operational effectiveness
• Lead global inspection strategies, inspection management, regulatory readiness, health authority engagement, and inspection response governance
• Oversee inspection observations, CAPAs, effectiveness evaluations, systemic remediation, and inspection outcomes
• Establish and drive end-to-end GxP vendor quality oversight, risk segmentation, KPIs/KQIs, and governance
• Lead investigations, root cause analysis, and CAPA management for internal and external quality events
• Provide quality leadership for combination products, diagnostics, IVD, on-body delivery systems, and digital health technologies
• Oversee design controls, human factors engineering, risk management, supplier quality, post-market surveillance, laboratory quality systems, assay validation, and diagnostic supplier quality
• Support Business Development, Licensing, and M&A through GxP due diligence, risk assessments, mitigation strategies, and post-deal integration
• Establish governance frameworks, councils, review boards, escalation forums, metrics, dashboards, and reporting
• Act as Operational Lead for the R&D Quality Council and support Enterprise Quality Council content generation
• Chair the GCP serious breach committee
• Design, implement, and continuously improve a modern, harmonized R&D QMS
• Oversee deviations, CAPAs, change control, quality events, training frameworks, knowledge management, and continuous learning
• Lead RDQ strategic projects from initiation through execution, including timelines, budgets, and measurable outcomes
• Provide leadership, coaching, development, performance management, and career planning for direct reports
• Attract and retain quality talent and foster cross-functional collaboration
• Represent BMS at external and cross-industry bodies
• Manage team and RDQ budgets when applicable

Executive Director, GxP Quality

• Provide strategic and operational quality leadership across all therapeutic areas from first-in-human through lifecycle management
• Oversee GxP compliance, inspection readiness, and quality culture across the development portfolio
• Serve as accountable Quality partner to Global Drug Development and Global Development Operations
• Define and drive therapeutic-area Quality oversight strategy
• Drive Trial Quality Health through Trial Quality Performance Narratives and GCP Consultation
• Provide proactive quality guidance and risk-based oversight to therapeutic-area, Drug Development, Clinical Operations, Regulatory Affairs, and Medical Affairs leadership
• Oversee quality risk assessments and escalation management for high-impact program decisions, regulatory submissions, and post-approval changes
• Represent R&D Development Quality at governance bodies and drive resolution of quality and compliance risks
• Ensure inspection readiness through proactive oversight, mock inspections, and CAPA management
• Lead quality investigations, root cause analysis, and CAPA management for quality events
• Oversee the GRS Quality Business Partner and quality integration into regulatory strategy, CMC submissions, and applicable manufacturing changes
• Oversee complex CMC/GRS issues, including out-of-specification investigations, manufacturing deviations, and regulatory agency queries
• Support data quality standards in RIM systems and related metrics
• Provide oversight and strategic direction for Medical Affairs and Lifecycle Management Quality Business Partnerships
• Embed quality oversight in non-interventional studies, health economics, patient support programs, post-approval programs, and medical affairs operations
• Assure QMS compliance for Medical Affairs-sponsored studies, patient support programs, and real-world evidence activities
• Lead quality review and oversight of promotional and medical affairs materials where required
• Partner on audit and continuous inspection readiness across therapeutic-area programs and Medical Affairs/Lifecycle Management portfolios
• Prepare for and manage FDA, EMA, PMDA, and other global health authority inspections
• Serve as primary quality contact during regulatory inspections and manage responses to observations and audit findings
• Track and trend inspection outcomes, quality events, and audit findings to drive systemic improvements and CAPA effectiveness
• Oversee quality systems for development, patient support programs, and medical affairs, including deviation management, CAPA, change control, and vendor qualification
• Establish and monitor quality metrics and KPIs; present quality performance and risk to senior leadership and governance bodies
• Escalate critical quality issues to senior Quality and GDD/GDO leadership
• Provide leadership, coaching, and development for direct reports
• Build team capability through coaching, performance management, and career development planning
• Attract and retain quality talent and resource the therapeutic-area Quality function
• Foster collaborative cross-functional partnerships
• Represent BMS at external and cross-industry bodies
• Manage team and R&D Development Quality budgets when applicable

Executive Director, Development Quality

Supply Chain

• Serve as legal advisor to the Global Supply Chain organization on complex issues affecting clinical and commercial product supply networks
• Advise on global trade matters including tariffs, trade remedies, customs and import/export compliance, economic sanctions, export controls, and trade-related licensing
• Develop practical trade compliance and mitigation strategies with Customs & Trade leads
• Advise on human rights matters including forced-labor due diligence, responsible sourcing, supply-chain transparency, and emerging human-rights laws and standards
• Assess risks and develop mitigation strategies with business and compliance stakeholders
• Monitor global trade and supply-chain regulations and enforcement trends
• Advise senior leadership on business impact, risk mitigation, and opportunities
• Draft, review, and negotiate complex supply, logistics, transportation, and warehousing agreements
• Advise on supply disruption, business continuity, and crisis-response matters
• Collaborate across Law & Policy, including regulatory, ESG, policy, litigation, and IP colleagues, to provide coordinated legal support

Senior Counsel, Supply Chain, Trade, Human Rights

General Counsel

• Serve as lead legal advisor to Global Product Development
• Counsel senior executives on business strategies and complex, high-value transactions across the pharmaceutical and biologics pipeline
• Negotiate, structure, and draft material development and supply transactions, including CMO/CDMO agreements
• Support legal due diligence on business development opportunities
• Support manufacturing, operations, and supply aspects of M&A and BD deals
• Support asset integration into the product development network
• Draft and negotiate assignment, manufacturing, material transfer, and bill of sale agreements
• Negotiate and draft drug development, procurement, manufacturing, laboratory, and research agreements
• Advise on enterprise-wide manufacturing strategy
• Identify potential risks and establish mitigation strategies
• Guide the Product Development & Supply team through alliance-related issues
• Partner with IP colleagues to protect and leverage product development innovations
• Lead process optimization and integration initiatives
• Streamline transactional legal support across the enterprise
• Collaborate across the Law & Policy Department and with business clients to deliver coordinated legal advice

Counsel, Global Product Development

• Serve as legal advisor to Pharma and Biologics Operations on complex legal, regulatory, and operational matters across the global manufacturing network
• Provide transactional and comprehensive legal support for internal and external manufacturing operations, including PDS Business Development matters
• Lead drafting and negotiation of highly complex CMO, manufacturing and supply, and collaboration agreements
• Support manufacturing, operations, and supply aspects of BMS M&A and business development transactions, including due diligence and integration
• Anticipate and proactively identify legal issues with an enterprise view
• Deliver clear, operational, and effective advice supporting informed business decisions
• Lead and organize functional and substantive working groups assessing significant legal issues
• Collaborate across the Law & Policy Department with business clients and colleagues to deliver coordinated, comprehensive legal advice

Senior Counsel, Pharma and Biologics Operations Law

Clinical Operations

• Develop clinical operational strategy and oversee global clinical study teams, CROs, and vendors
• Ensure studies are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines
• Oversee 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
• Lead cross-functional study execution teams in achieving study goals and deliverables
• Proactively escalate issues to key internal stakeholders for timely resolution
• Perform oversight review and quality control of CRO and vendor activities
• Ensure compliance with key performance metrics and inspection readiness
• Support CRO and vendor governance meetings and contribute to governance structures, plans, performance data, and risk escalations
• Drive continuous process improvement and implementation of best practices
• Ensure global inspection readiness and lead interactions during regulatory inspections
• Leverage AI tools to enhance individual productivity and quality of work
• Perform other related duties as assigned

Associate Director, Clinical Operations

Operations

• Serve as the operational architect for BMS's Medical Evidence Generation enterprise
• Build and scale a fit-for-purpose operational model for medical studies across oncology, hematology, immunology, cardiovascular disease, and neuroscience
• Lead an organization of approximately 50 people
• Assess the current state and redesign organizational structure, roles, levels, and accountabilities
• Ensure the team is equipped to execute the medical evidence generation portfolio at scale and with excellence
• Own the enterprise-wide operational strategy for medical study execution
• Design medical-specific operational frameworks distinct from the drug development model
• Create adaptable frameworks for interventional, observational/non-interventional, and externally sponsored studies
• Identify talent gaps and partner with HR to address under-resourced areas
• Establish governance frameworks ensuring compliance with global and local regulations, ICH guidelines, GCP, and BMS standards
• Implement standardized yet adaptable operational policies and procedures
• Provide senior oversight across the full study lifecycle, from budget conception, feasibility, and timeline planning through site activation, data collection, monitoring, and closeout
• Identify, assess, and mitigate operational risks and implement corrective and preventive actions
• Oversee CRO and vendor partnerships
• Represent MEG Operations as an enterprise leader and key decision-maker on the MEG, MAP & RWE Leadership Team
• Set the vision for the evolution of medical operations at BMS
• Align operational strategy with medical portfolio priorities
• Translate high-level strategy into executable operational plans
• Champion innovation and continuous improvement, including digital tools, data platforms, and process enhancements

Executive Director, Global Medical Operations

Executive

• Provide high-level administrative, operational and coordination support to senior leaders and extended leadership within MEG, MAP & RWE
• Manage phones, complex calendars, meeting scheduling and logistics, domestic and international travel arrangements, and expense reports
• Proactively manage schedules, anticipate conflicts, identify priorities, and coordinate solutions
• Prepare leaders for meetings by assembling materials, assisting with PowerPoint presentations, coordinating preparatory meetings, and preparing pre-reads
• Handle confidential business information, organizational matters, personnel activities, and leadership communications with professionalism and discretion
• Coordinate logistics for leadership meetings, town halls, offsites, team meetings, workshops, and strategic business reviews
• Identify opportunities to improve efficiency, streamline processes, and enhance team effectiveness
• Manage SharePoint sites, OneDrive repositories, electronic filing systems, distribution lists, organizational communications, and other business tools
• Create, edit, and track job requisitions and personnel-related transactions
• Support onboarding, organizational changes, department initiatives, business processes, governance activities, budget-related tasks, and special projects
• Serve as a collaborative partner across MEG, MAP & RWE, supporting communication, coordination, and operational excellence

Executive Associate

Medical Director

• Provide strategic and operational leadership for the Medical Evidence Generation trial portfolio within an assigned therapeutic area
• Serve as direct line manager for Global Trial Leads, including hiring, onboarding, workload allocation, performance management, coaching, and career development
• Balance resourcing and workload across the therapeutic area's trial portfolio and resolve capacity gaps
• Foster an inclusive, high-performing team culture and champion training, professional development, and knowledge-sharing
• Set performance objectives, conduct one-on-ones, provide feedback, and deliver performance reviews
• Provide operational oversight across all medical trials in the assigned therapeutic area
• Escalate and resolve complex operational issues, risks, and cross-study dependencies
• Report portfolio performance metrics, budget status, and risk indicators to senior MEG Operations leadership
• Drive standardization of best practices, operational tools, systems, and reporting across the portfolio
• Represent MEG Operations in medical governance forums and support study endorsement decisions
• Provide therapeutic and operational guidance on study protocols and execution strategies
• Advise teams and leadership on trends, risk mitigation, and operational excellence
• Plan study timelines and budgets with cross-functional teams and Finance
• Lead quarterly budget reviews, forecast variances, and resolve budget and timeline issues
• Oversee therapeutic-area vendor logistics, vendor selection, evaluation, relationships, invoices, accruals, and scope amendments
• Oversee strategic planning and execution of multiple medical trials from start-up through close-out
• Lead, support, and coordinate cross-functional study teams and internal and external contributors
• Analyze operational metrics to optimize study execution and align with franchise objectives
• Build strategic partnerships with Medical/Clinical Research, Affiliates, CROs, AROs, and other collaborators
• Support CRO and vendor scopes of work and ensure alignment with contracts, budgets, and quality standards
• Maintain accurate study data records in systems such as Veeva CTMS and eTMF
• Develop and enforce trial-specific standards and lead cross-functional and global best practices

Director, Medical Evidence Generation Operations Lead – Multiple Openings

General

• Own end-to-end operational accountability for global medical studies from start-up through close-out
• Partner with the MEG Lead and internal study teams to deliver studies on time, within budget, and to quality standards
• Oversee operational activities of internal and external contributors
• Manage CRO and vendor scopes of work, contracts, budgets, quality standards, invoices, accruals, and amendments
• Participate in vendor selection and evaluation
• Monitor performance metrics and quality indicators
• Maintain accurate records in Veeva, CTMS, eTMF, and related study management systems
• Develop and enforce study-specific operational standards and global best practices
• Maintain action logs, decision trackers, issue registers, and risk mitigation plans
• Provide operational guidance on study execution, risk mitigation, and operational excellence
• Plan study timelines, budgets, vendor logistics, and resource requirements
• Lead quarterly budget reviews and collaborate with Finance on forecasting
• Serve as the primary escalation point for study operational matters
• Ensure administrative activities such as eTMF uploads and reviews, CTMS maintenance, and finance reconciliation are completed
• Represent operational execution at asset- and therapeutic-level governance forums and lead global initiatives as needed

Global Trial Lead – multiple openings

Analyst

• Own key trial-level analytics workstreams, including enrollment forecasting, feasibility analysis, and protocol input
• Translate structured study requirements into analytical deliverables with senior TAIP colleagues
• Work within a specific clinical trial context to support operational strategy, protocol logic, and trial planning
• Build therapeutic area knowledge and contribute to targeted, scientifically grounded analyses
• Ensure accuracy, consistency, and clarity in data models, dashboards, and study-team insights
• Collaborate across geographies with analysts and global team members
• Contribute to cost analyses, including country mix optimization and study design trade-offs
• Analyze site and patient burden, competitor activity, and external data to support study optimization
• Coordinate with field-based colleagues to integrate local insights into feasibility and planning analytics
• Use trial analytics platforms and tools to generate, structure, and communicate data-driven insights
• Support analytics informing clinical supply forecasting or site-level supply considerations
• Analyze complex data, challenge assumptions, and generate strategic, evidence-based recommendations

Senior Director, Aseptic Operational Support

Clinical Research Associate

Clinical Research Associate

Translational Program Manager – Solid Tumor Translational Development

Executive Director, GxP Quality

Executive Director, Development Quality

Senior Counsel, Supply Chain, Trade, Human Rights

Counsel, Global Product Development

Senior Counsel, Pharma and Biologics Operations Law

Associate Director, Clinical Operations

Executive Director, Global Medical Operations

Executive Associate

Director, Medical Evidence Generation Operations Lead – Multiple Openings

Global Trial Lead – multiple openings

Senior Analyst, Trial Analytics, Insights & Planning