Bristol Myers Squibb

Risk

• Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
• Partner with Drug Development, in particular the CORM function, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
• Provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.
• At the study level, conduct spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
• Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
• Provide quality and compliance consultation to clinical trials teams (where relevant, in partnership with CORM) throughout study lifecycle.
• Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.

Associate Director, Quality Risk Specialist

Research Scientist

• Perform computational research and integrative analyses on multimodal biological profiling datasets (e.g. transcriptomic, proteomics, single cell omics, spatial profiling) to support early pipeline programs
• Apply machine learning, and other advanced computational/ statistical approaches, to compare high-dimensional experimental readouts from perturbation experiments/screens (e.g. CRISPR screens, perturb-seq, cellular imaging) to disease states defined by patient data and work as part of a cross-functional team to nominate and validate new targets for Neuro, Cardiovascular and autoimmune diseases indications
• Work with external partners in industry, academia, and pre-competitive collaborations (e.g. NIH Accelerating Medicines Partnership) on novel computational and experimental approaches
• Communicate findings and recommend follow-up actions in multiple settings (including 1:1, seminars, and team meetings)

Principal Scientist, Computational Biology

Director

• Lead the development and execution of Patient Safety mission, vision, and strategic priorities to improve patient safety outcomes globally.
• Serve as a trusted strategic advisor and Chief of Staff to the Head of Worldwide Patient Safety, enabling effective operation, decision making, and execution of the PS Senior Leadership Team.
• Shape and drive Patient Safety organizational evolution, including operating model design, people and culture strategy, and capability modernization across data, digital, and analytics.
• Govern prioritization of Patient Safety investments and initiatives, ensuring resources are allocated to the highest value opportunities across transformation, process optimization, and digital enablement.
• Own and manage the Patient Safety budget, ensuring alignment with strategic priorities and delivery against financial commitments.
• Lead and develop a high performing, global BCE leadership team; accountable for strategy, planning, capability building, digital enablement, business operations, and future focused skill development.
• Provide enterprise grade change management, communications, and engagement leadership in support of Patient Safety strategy and transformation; sponsor Patient Safety engagement networks.
• Build strong, trusted partnerships with internal and external stakeholders (e.g., IT, HR, GBDS, Medical Affairs, Regulatory, enterprise transformation teams) to advance Patient Safety objectives and ensure adoption of enterprise capabilities.
• Define, mature, and measure the effectiveness of Patient Safety business capabilities, ensuring scalability, sustainability, and value realization.
• Oversee identification, evaluation, experimentation, and scaling of innovation, automation, and process redesign opportunities based on demonstrated business impact.
• Ensure Patient Safety readiness to support Digital Health initiatives and proactively shape opportunities where digital innovation can enhance patient safety and informed treatment decisions.
• Lead the Patient Safety Project Management Office, ensuring disciplined portfolio planning, prioritization, execution, measurement, and transparent communication of initiatives.
• Accountable for Patient Safety publications and external scientific communications strategy, ensuring high quality engagement with regulators and the broader pharmacovigilance community.
• Represent Bristol Myers Squibb Patient Safety through thought leadership and participation in external consortia, forums, and conferences.

Executive Director, Business Capabilities – Excellence

Therapist

• To define and shape the Quality strategy for global Contract Manufacturing Organizations (CMO) and associated Contract Test Labs (CTLs) management for the Cell Therapy External Manufacturing (ExM) network.
• To ensure a high level of cGMP compliance and the safety, efficacy, and quality of externally manufactured commercial products.
• To lead a team of Quality Senior Directors or others in the oversight of the External Manufacturing Network.
• To recruit and develop global talent to sustain local and global competitiveness.
• To support audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs.

Senior Director, External Manufacturing Quality, Cell Therapy

• Develop the Quality Performance Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
• As part of the upstream protocol authoring process, partner with Drug Development, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
• During trial conduct, provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.
• This will involve partnering with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.
• At the study level, conduct spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
• Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
• Support for cause, critical and/or complex quality issues as well as serious breaches for the TA, where deemed necessary.
• Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.
• Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
• Actively participate in SOP reviews and provide feedback to relevant stakeholders, as applicable.
• Establish strong partnership with business stakeholders.
• Partner with the study teams to ensure effective management of significant quality events / noncompliance and protocol deviations for CtQ data, processes and vendors. For e.g. lead investigations, root cause analysis and support CAPA plan development.
• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
• Provide R&D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.
• Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
• External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.
• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.
• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.
• Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.
• Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines.
• May influence the external environment through interactions with regulators, trade associations, or professional societies.
• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

Associate Director, Asset Quality

• Be responsible for ensuring optimal development of China biomarker testing strategy aligned with global strategy.
• Identify scientific gaps or a specific tailored biomarker strategy relevant for China for a certain asset.
• Oversee the general execution of China biomarker testing in clinical studies and provide guidance and leadership in troubleshooting when applicable.
• Be responsible for overseeing the PDx development strategy/execution in China.
• Be responsible for driving local biomarker research projects in China.
• Collaborate effectively with an integrated organizational framework across translational medicine, biomarker and R&D (in China and globally).
• Coordinate the China biomarker/precision medicine sub-teams for specific diagnostic products or indications to enhance the value of the assets through incorporation of diagnostic biomarkers into exploratory, clinical, regulatory, and Medical/Commercial strategies.
• Form alliances across scientific disciplines and participate in the decision-making process that typically require developing new options to solve highly complex problems for the completion of team goals.
• Provide internal and external subject matter expertise for BMS Precision Medicine activities in China.
• Expand and strengthen external networks through collaboration with external partner/vendor, interaction with local HA, interaction with industry association and academic institutes in China.
• Acquire and disseminates precision medicine knowledge for organizational learning and capability in China.

Director, China Precision Medicine Lead

• Monitor, analyze, and interpret federal and state developments related to the 340B Drug Pricing Program, including legislation, regulatory proposals, litigation activity, and administrative guidance.
• Assess the potential business, operational, and patient access implications of 340B-related policy and enforcement trends; develop summaries, insights, and recommendations for senior leaders.
• Support development of BMS 340B policy positions, advocacy strategies, and engagement plans in partnership with Federal and State Government Affairs, Legal, Market Access, and other internal stakeholders.
• Draft and contribute to policy materials including talking points, issue briefs, legislative concepts, comment letters, external-facing statements, and internal education materials.
• Provide guidance to cross-functional colleagues on 340B-related policy risks and opportunities, ensuring consistent internal alignment and messaging.
• Support engagement with federal and state policymakers, agencies, and trade associations to help shape discussions related to modernization, oversight, program integrity, and related reform proposals.
• Track and assess interaction between 340B and broader federal and state health policy developments (e.g., Medicaid policy, pricing reforms, demonstration models).
• Assist in developing tools and resources for federal and state advocacy teams to use in external engagement.
• Represent BMS in policy forums, workgroups, and industry discussions as appropriate.
• Support internal governance, coordination, and briefing processes related to 340B policy strategy.

Associate Director, U.S. Policy, Research

• Lead the U.S. Policy Analytics sub-team, serving as a strategic thought partner to the U.S. Policy and Government Affairs leadership, and across the Global Policy and Government Affairs organization.
• Proactively identify, prioritize, and shape the U.S. policy analytics agenda, aligning analytics efforts with policy research evidence needs and external policy engagement strategies.
• Provide analytics support in close collaboration with Global Policy and Government Affairs (GPGA), Global Health Systems Analytics, Global Market Access (MAx), Global Pricing, Legal, Health Economics & Outcomes Research (HEOR), Finance, and Business Insights & Technology (BIT).
• Build, maintain, and oversee financial and policy models assessing the impact of U.S. pricing and reimbursement policies across the BMS portfolio.
• Interpret complex statutes, regulations, and policy guidance, translating policy developments into actionable insights to inform enterprise strategic planning and decision making.
• Integrate analytical insights into executive level presentations and briefings that clearly communicate implications, tradeoffs, and recommendations to senior leadership.
• Oversee analytics that shape evidence based external policy engagement and advocacy strategies, in close partnership with policy leads and senior stakeholders.
• Serve as a representative for Global Policy Analytics in organizational forums and leadership meetings, providing strategic updates, insights, and recommendations.
• Lead, mentor, and develop direct reports, fostering a high performing, collaborative, and inclusive team culture.
• Champion the adoption and integration of generative AI tools and digital solutions to enhance analytical rigor, efficiency, and scalability across the team.

Senior Director, US Policy Analytics

Operations

• Coach sites and site leaders in the development and execution of COMPASS Roadmaps leveraging the BMS operating system to deliver results and mature Operational Excellence culture
• Apply Continuous Improvement and Lean tools to consistently improve performance, reduce waste and drive productivity across PDS sites and functions
• Support and influence changes to operations and processes; support movement to an organizational ‘Lead with Data’ mindset and fact-based decision-making culture
• Contextualize critical business issues and value levers, work to embed an objective and unbiased point of view into the business conversation with stakeholders, using the ability to communicate complex quantitative analysis in a clear, concise, and actionable manner
• Build customized organizational capability plans that meet the needs of the OpU
• Develop comprehensive data collection, performance reporting and review mechanism
• Design/architect analytics solutions including data transformation, data visualization, statistical analysis, modeling platforms, data manipulation software and visualization tools
• Establish and maintain clear and ambitious SMART KPIs to ensure that organization objectives in the areas of safety, quality, service, cost and efficiency are met
• Business Process Improvement - Define, optimize and maintain end-to-end business processes
• Lead workshops, Kaizen, DMAIC, PDCA and Lean Six Sigma Projects
• Partner with leadership to identify high impact opportunities, execute process improvements and drive initiatives across the organization
• Identify and eliminate process inefficiencies, bottlenecks, and waste to enhance productivity and reduce costs
• Deployment of Governance Systems & Visual Management Systems
• Root cause problem solving
• Optimization of Labor, Facility, and Space Utilization
• Identification of meaningful Metrics and Key Performance Indicators (KPIs)
• Continuous Improvement Education, Training, Project Intake, and Prioritization
• Build organizational capability and provide training/coaching
• Building, maintaining and leveraging relationships across the matrix to identify opportunities for process improvement and facilitate the implementation of measurement and management systems
• Ensure compliance with organizational policies and procedures related to resource management
• Stay current with industry trends and emerging technologies related to Compass and process improvement
• Implement innovative solutions to drive process improvements and enhance business performance
• Foster a culture of innovation and continuous improvement within the organization
• Travel up to 50%

Director, Operational Excellence

Marketing

• Brand Strategy
• Working with cross-functional teams to provide key customer insights and input on strategy, tactics, messaging, and program execution
• Supporting the execution of approved Advisory Board
• Assist in identification of Healthcare Professional (HCP) consultants based on profile established by the approved Consultant Engagement Project Brief
• Facilitate, participate in and attend advisory boards, where appropriate
• Regional and National Physician Discussions
• Supporting disease state, and approved on-label and consistent with label product conversations focused on key topics utilizing approved promotional messaging and PReP approved materials
• Engage with assigned TLs and solicit feedback, as necessary
• Participating in and attending Congresses and other industry meetings
• Conduct 1:1 meeting with HCPs
• Attend meeting sessions at the congress
• Compliant Collaboration with other Field-based and Home Office-based teams
• Providing input and support in developing account plans for Sales
• Speaker Management and Engagement
• Identifying and developing HCP Speakers to provide high-quality compliant promotional education
• Providing refresher and follow-up training to Speakers on approved Speaker materials
• Ensuring appropriate and compliant execution of branded and unbranded Speaker programs in compliance with BMS guiding principles
• Monitoring Speaker performance at live Programs for the purpose of evaluating speaker effectiveness and capabilities
• Works with home office Marketing, Sales, and cross-functional teams to provide key customer insights and input on strategy, tactics, and messaging, and program execution.
• Assists in the development of Home Office Brand Strategy and in the execution of the strategy in the Regions
• Compliance & Integrity Working with the highest degree of professionalism and in accordance with applicable BMS policies and governing laws, rules and regulations, industry codes, and the company’s Principles of Integrity.

Associate Director, Hematology Regional Marketing – Mid West

• Working with cross-functional teams to provide key customer insights and input on strategy, tactics, messaging, and program execution.
• Supporting the execution of approved Advisory Board.
• Assist in identification of Healthcare Professional (HCP) consultants based on profile established by the approved Consultant Engagement Project Brief.
• Facilitate, participate in and attend advisory boards, where appropriate.
• Supporting disease state, and approved on-label and consistent with label product conversations focused on key topics utilizing approved promotional messaging and PReP approved materials.
• Engage with assigned TLs and solicit feedback, as necessary.
• Participating in and attending Congresses and other industry meetings.
• Conduct 1:1 meeting with HCPs.
• Attend meeting sessions at the congress.
• Providing input and support in developing account plans for Sales.
• Identifying and developing HCP Speakers to provide high-quality compliant promotional education.
• Providing refresher and follow-up training to Speakers on approved Speaker materials.
• Ensuring appropriate and compliant execution of branded and unbranded Speaker programs in compliance with BMS guiding principles.
• Monitoring Speaker performance at live Programs for the purpose of evaluating speaker effectiveness and capabilities.
• Works with home office Marketing, Sales, and cross-functional teams to provide key customer insights and input on strategy, tactics, and messaging, and program execution.
• Assists in the development of Home Office Brand Strategy and in the execution of the strategy in the Regions.

Associate Director, Hematology Regional Marketing – East

• Drives innovative and efficient study design.
• Develops study designs that address study objectives that will support regulatory approval, medical research and market access.
• Independently leads, initiates, and oversees the statistical support for the development of compounds within a therapeutic area Provides guidance and management to statisticians to ensure high quality and timely deliverables.
• Effectively engages as a matrix team member on high level development teams, to act as a scientific and strategic partner in the drug development process Presents and defends complex statistical solutions to all levels of BMS governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provide influence on key decisions Contributes to Clinical Development Plans, leads GBDS related submission activities, and post-submission strategies/ preparations/defenses.
• Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information. Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable Contributes to creation/maintenance of and provide training on statistical topics departmental SOPs.
• Provides guidance and management to statisticians to ensure high quality and timely deliverables.
• Manages a functional or project budget, and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards therein.
• Represents BMS at professional societies, and in industry-wide technical discussions. Contributes to the statistical community of practice Provides active coaching to biostatistical team members when developing solutions to problems. Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
• Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. Applicable to people managers • Effectively engages as an employee advocate and management coach/mentor to team members both internally and externally • Provides leadership to empower and develop the team. • Provides guidance to employee's development plans and carries out performance review and feedback. Develops performance metrics for staff.

Director, Biostatistics

• Providing comprehensive leadership of the eCOA Management function ensuring the technology, end to end processes, roles and vendor partnerships are optimized and in line with industry standards and regulatory requirements.
• Ensuring quality development and timely delivery of eCOA instruments and devices that are designed in accordance with documented specifications, as well as industry and BMS standards.
• Delivering eCOA for studies across Therapeutic Areas, including complex Neuroscience rater studies.
• Ensuring data acquired through eCOA meets quality standards, is readily consumable by downstream functions and is reliable for analysis.
• Ensuring processes related to acquisition and review of eCOA data are well defined, comprehensive, consistent across vendors, and effectively executed across all studies.
• Leading initiatives to establish industry-leading eCOA capabilities and processes, driving projects from start to finish.
• Holding accountability to resolve complex issues and proactively develop solutions, within the function and across functions.
• Managing the eCOA book of work and ensuring delivery of initial development and post-production changes for studies.
• Leading a global team of eCOA Management professionals that contribute significantly to the BMS portfolio of clinical trials.

Director, eCOA Management

• Create and communicate a vision for designing, conducting and executing innovative clinical development plans
• Supervise the development, monitoring, analysis and interpretation of clinical trials
• Drive overall strategy for malignant hematology while ensuring a franchise overall portfolio view
• Provide strategic insights into the clinical development plans
• Lead clinical input for search and evaluation activities in business development and diligence efforts
• Chair departmental Staff Meetings, PRC and represent governance meetings on an ad hoc basis
• Build a franchise reputation that attracts innovators to bring their ideas to BMS
• Develop a Clinical Development strategy to develop programs from research into First-In-Human testing and up to the achievement of Proof of Concept
• Lead and develop a group of Clinical Development professionals

Executive Director, Global Clinical Development, Early Hematology and Cell Therapy

• Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy.
• Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols.
• Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents.
• Presents summary data and analyses results, in a clear, concise, complete, and transparent manner.
• Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information.
• Manages multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area.
• Applies extensive knowledge of statistical / clinical trials methodology as it relates to clinical development.
• Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments with demonstrated application to study design.
• Effectively engages as a matrix team member on project teams, to act as a scientific and strategic partner in the drug development process.
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable.
• Contributes to external and internal statistical community of practice.
• Develops & advises team members.
• Effectively communicates the DQS Mission and Vision in a fashion that generates pride, excitement and commitment within DQS.