Sr.Director, Clinical Data Management, Oncology

Bristol Myers Squibb • Princeton, NJ

27d • $234,570 - $284,249 • Hybrid

About The Position

The Senior Director, Clinical Data Management (CDM), Oncology is a senior leadership role providing strategic and operational leadership for the CDM function within Data and Agentic Operations across the oncology portfolio. The role plans and coordinates the timely delivery of complete, high-quality, reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance. It leads modernization of CDM into a technology-enabled, risk-based function, using automation, advanced analytics, and responsibly governed AI/ML to improve data quality, shorten cycle times, and reduce the burden on sites and patients while maintaining compliance with applicable regulations and health authority expectations.

This is a full-time office-based position requiring attendance in the office 50% of the time over two weeks. Periodic travel may be expected for global team locations, vendors, and industry forums. The position leads a global team and partners broadly across R&D, including Clinical Development, Biostatistics and Programming, Clinical Operations, Biomarkers, Regulatory, Quality, and Digital/IT. It also oversees vendors, supports financial and capacity planning, and represents the company in external industry groups.

Requirements

• Bachelor’s degree in life sciences, health informatics, data science, computer science, or a related discipline.
• At least 15 years of relevant industry experience in clinical data management or closely related clinical data functions.
• 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.
• Expert understanding of drug development, clinical trial execution, data, and systems.
• Expert knowledge of GCP/ICH guidelines, including ICH E6(R3), and data standards.
• Proven ability to lead a function and sizeable global team, resolve complex issues, and drive significant initiatives to completion.
• Ability to lead and make decisions with an enterprise mindset, considering what is best for the company and patients.
• Technical breadth to serve as a credible interface with global development and business partners.
• Broad understanding of the clinical trial environment across key regions and ability to anticipate future trends and impacts.
• Strong influential leadership and communication skills, including ability to engage, manage, develop, and inspire a geographically diverse team.
• Demonstrated partnership across collaborative and industry forums.
• Expert knowledge of industry trends and emerging technologies for clinical trial data acquisition and management, including AI/ML, generative AI, automation, RBQM, and modern cloud data platforms.
• Practical understanding of the capabilities and limitations of ML- and LLM-based tools, including the ability to challenge claims regarding training data, validation, bias, explainability, and performance.
• Working knowledge of regulatory expectations for AI in drug development, including the FDA risk-based credibility framework and FDA/EMA good AI practice principles, and ability to apply them to CDM use cases.
• Uses metrics, analytics, and data visualization to steer operations and demonstrate value.
• Proven change leadership introducing technology and new ways of working, reskilling teams, and sustaining adoption.
• Familiarity with clinical data platforms and ecosystems, including EDC, eCOA, IRT, and data integration and review tools, sufficient to set architecture and vendor direction.

Nice To Haves

• Advanced degree such as an MS, PharmD, PhD, or MBA.
• Professional certification such as CCDM or PMP, or formal training in data science/AI.
• Experience deploying GxP-validated AI/ML or generative AI solutions.
• Experience with novel oncology modalities such as cell therapy, ADCs, or radiopharmaceuticals.
• CRO/FSP governance experience at scale.

Responsibilities

• Define the strategic vision, multi-year roadmap, and operating model for the oncology CDM organization.
• Provide CDM leadership for oncology programs and tumor types, including oversight and governance of data deliverables for high-value and registrational trials.
• Shape data acquisition strategy for evolving oncology trial designs and data types, including adaptive and master-protocol studies, tumor response and imaging, biomarkers and genomics, patient-reported outcomes, and real-world data.
• Build productive partnerships across BMS and think strategically across R&D.
• Support and execute the CDM AI and automation strategy, identifying and prioritizing high-value use cases.
• Lead the shift from retrospective, manual data cleaning to continuous, risk-based, near-real-time data review and surveillance in partnership with Clinical Operations 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 through process and role redesign, change management, and tracking benefits such as cycle time, query volume, data quality, cost, and site burden.
• Oversee and govern CDM deliverables across the study lifecycle, including start-up, conduct, database lock, and archival, across EDC and other clinical data sources.
• Deliver against CDM operational performance metrics and KPIs and report performance to senior leadership.
• Resolve complex cross-study issues and drive significant initiatives to completion.
• Ensure efficient, effective, and compliant working practices aligned with GCP, ICH E6(R3), 21 CFR Part 11, EU Annex 11, data privacy regulations, and computerized system validation requirements.
• Maintain inspection readiness for CDM processes, systems, and documentation; represent CDM in health authority inspections and audits and ensure effective CAPA.
• Ensure adherence to data standards such as CDISC and delivery of submission-ready data supporting regulatory filings.
• 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.
• Lead a global team of CDM professionals, providing feedback, coaching, and career development while supporting engagement, retention, and accountability.
• Build team capabilities in data and AI literacy, analytical skills, and working with AI-enabled tools.
• Communicate goals, priorities, and business-critical information to engage and energize employees.
• Promote a workplace culture that values diversity of thought, integrity, coaching, and accountability.
• Represent the company with external organizations, committees, and industry groups relating to clinical data acquisition and management, including emerging technology and AI practices.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• 11 paid company holidays each year.
• For eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include 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 receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior