Sr.Director, Clinical Data Management, Oncology

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Job Title Senior Director, Clinical Data Management, Oncology Division Research and Development (R&D), Data and Quantitative Science (DQS), DD Data and Agentic Operations Functional Area Description Data and Agentic operations team is responsible for the acquisition of clinical trial data and for ensuring the completeness and integrity of the acquired data for trials across the BMS R&D portfolio. The function is advancing toward a data-driven, automated, and AI-enabled operating model that delivers submission-quality data faster and with less burden on sites and patients. Position Summary The Senior Director, Clinical Data Management (CDM), Oncology is a senior leadership role providing strategic and operational leadership of the CDM function within Data and Agentic operations for the oncology portfolio. The role plans and coordinates the timely delivery of complete, high-quality, and reliable clinical trial data used for internal decision-making, regulatory approval, and market acceptance. The role also leads the modernization of CDM into a technology-enabled, risk-based function, applying automation, advanced analytics, and responsibly governed AI/ML to improve data quality, shorten cycle times, and reduce site and patient burden, while maintaining compliance with GCP, ICH E6(R3), and evolving health authority expectations for AI in drug development. This is a full-time office-based position with the requirement to be in office 50% of the time over 2 weeks. Position Responsibilities Strategy and Portfolio Leadership Define the strategic vision, multi-year roadmap, and operating model for the oncology CDM organization, including the innovative solutions required to create an industry-leading CDM capability. Provide CDM leadership for diverse oncology programs and tumor types within the CDM organization, with oversight and governance of data deliverables for high-value and registrational clinical trials. Anticipate and shape data acquisition strategy for evolving oncology trial designs and data types, such as adaptive and master-protocol studies, tumor response and imaging data, biomarker and genomic data, patient-reported outcomes, and real-world data. Build strong, productive partnerships with key stakeholders across BMS (Clinical Development, Biostatistics and Programming, Clinical Operations, Biomarkers, Regulatory, Quality, Digital/IT) and think strategically across R&D. AI, Automation, and Data Innovation Support and execute the AI and automation strategy for CDM, identifying and prioritizing high-value use cases such as ML-assisted and centralized data review, anomaly and outlier detection, automated query generation and management, medical coding, CRF/edit-check and data-transfer specification support, external data reconciliation, and standards mapping support. Lead the shift from retrospective, manual data cleaning to continuous, risk-based, near real-time data review and surveillance, in partnership with Clinical Operations (RBQM) and Biostatistics. Ensure responsible and compliant use of AI, including generative AI and large language models, with attention to patient privacy, data confidentiality, data integrity and explainability. Drive adoption and measurable value: redesign processes and roles, lead change management, and track benefits such as cycle time, query volume, data quality, cost, and site burden. Oversight and Delivery Ensure oversight and governance of CDM deliverables across the study lifecycle (start-up, conduct, database lock, archival), covering EDC and other clinical data sources including eCOA/ePRO, imaging, central lab, and biomarker data. Deliver consistently on functional performance metrics and KPIs of CDM operations (for example, start-up and database lock timelines, query aging, data quality and completeness) and report performance to senior leadership. Resolve complex, cross-study issues and drive significant initiatives to completion. Quality, Compliance, and Inspection Readiness Ensure efficient, effective, and compliant working practices that deliver high-quality clinical trial data, in line with GCP, ICH E6(R3), 21 CFR Part 11, EU Annex 11, data privacy regulations, and computerized system validation requirements. Accountable for inspection readiness of CDM processes, systems, and documentation; represent CDM in health authority inspections and audits and ensure effective CAPA. Ensure adherence to data standards (e.g., CDISC) and the delivery of submission-ready data supporting regulatory filings. Vendors, Partners, and Financial Management Set sourcing strategy and govern CRO, FSP, and technology data vendor performance, including selection, oversight, KPIs, and escalation. Support departmental budget, resource forecasting, and capacity planning for the oncology CDM portfolio. People Leadership and Culture Lead a global team of CDM professionals, providing ongoing feedback, coaching, and career development opportunities; focus on engagement and retention, and hold staff accountable for high-quality performance. Build future-ready capabilities in the team, including data and AI literacy, analytical skills, and comfort working alongside AI-enabled tools. Communicate goals, priorities, and business-critical information to engage and energize employees. Develop and promote a workplace culture that values diversity of thought, promotes integrity, and fosters coaching and accountability. External Engagement Represent the company with key external organizations, committees, and industry groups relating to clinical data acquisition and management, including engagement on emerging technology and AI practices. Degree Requirements Required: Bachelor’s degree in life sciences, health informatics, data science, computer science, or a related discipline. Preferred: Advanced degree (e.g., MS, PharmD, PhD, MBA). Professional certification (e.g., CCDM, PMP) or formal training in data science/AI is an asset. Experience Requirements At least 15 years of relevant industry experience in clinical data management or closely related clinical data functions, with substantial experience managing staff in a global setting, including leading managers. Oncology clinical trial experience, including late-phase or registrational studies. Demonstrated experience leading or sponsoring CDM modernization with measurable results, such as automation, risk-based data review, advanced analytics, or AI/ML-enabled capabilities. Experience supporting health authority inspections and regulatory submissions. Preferred: Experience deploying GxP-validated AI/ML or generative AI solutions; experience with novel oncology modalities (e.g., cell therapy, ADCs, radiopharmaceuticals); CRO/FSP governance at scale. Key Competency Requirements Domain and Leadership Expert understanding of the drug development process and clinical trial execution , data and systems. Expert knowledge of GCP/ICH guidelines, including ICH E6(R3), and of data standards. Substantial experience leading a function and sizeable global team, with a proven record of resolving complex issues and driving significant initiatives to completion. Expert ability to lead and make decisions with an enterprise mindset, considering what is best for the company and for patients. Diverse technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory, quality, etc.). Broad intelli