Sr.Director, Clinical Data Management, Oncology
Bristol-Myers Squibb Company
Get a reply from this employer
Your resume and cover letter, tailored to exactly what they’re hiring for.
Benefits offered by this job
Job summary
Bristol Myers Squibb Company in New Jersey seeks a Senior Director to lead Clinical Data Management for oncology, shaping strategy and delivering high‑quality data for regulatory submissions.
You will modernize CDM with AI/ML, drive risk-based data monitoring, and collaborate across Clinical Development, Biostatistics, and Regulatory to shorten cycle times while ensuring compliance and data integrity.
Qualifications
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- 15+ years in clinical data management with oncology focus.
- Experience modernizing CDM with automation and AI/ML capabilities.
Responsibilities
- Define strategy, roadmap, and operating model for oncology CDM.
- Lead CDM for diverse oncology programs with governance of data deliverables.
- Drive AI/automation initiatives for data review and QC.
- Ensure GCP/ICH compliance and inspection readiness.
Skills
Education
Tools
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.
Senior Director, Clinical Data Management, Oncology
Research and Development (R&D), Data and Quantitative Science (DQS), DD Data and Agentic Operations
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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.
- 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.
- 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 intelligence of the clinical trial environment across key regions and anticipation of future trends and impact.
- Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop, and inspire a geographically diverse team.
- Demonstrated partnership across various collaborative and industry forums.
- Expert knowledge of industry trends and emerging technologies supporting clinical trial data acquisition and management, including AI/ML, generative AI, automation, RBQM, and modern cloud data platforms.
- AI fluency and judgment: practical understanding of what ML and LLM-based tools can and cannot do; able to challenge vendor and internal claims on 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 the ability to apply them to CDM use cases.
- Data-driven decision making: uses metrics, analytics, and data visualization to steer operations and demonstrate value.
- Change leadership: proven ability to introduce new technology and ways of working, reskill teams, and sustain adoption.
- Familiarity with clinical data platforms and ecosystems (EDC, eCOA, IRT, data integration and review tools) sufficient to set architecture and vendor direction.
Periodic travel can be expected (e.g., global team locations, vendors, and industry forums).
N/A
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.
- Madison - Giralda - NJ - US: $234,570 - $284,249
- Princeton - NJ - US: $234,570 - $284,249
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.
- 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 https://careers.bms.com/benefits
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
BMS is 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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS 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: https://careers.bms.com/california-residents/
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .
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 TAEnablement@bms.com 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.
R1607400 : Sr.Director, Clinical Data Management, Oncology
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
