, Clinical Data Management, Oncology

At Bristol Myers Squibb our employees often ask Who are you working fora 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: Bachelors 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 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.

Technology Data and AI

• 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.

Travel Required (nature and frequency)

Periodic travel can be expected (e.g. global team locations vendors and industry forums).

Describe exposure to any hazards/disagreeable conditions in the work environment

N/A

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

Compensation Overview:

Madison - Giralda - NJ - US: $234570 - $284249 Princeton - NJ - US: $234570 - $284249

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.

Benefits:

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 Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

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 People with Disabilities

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R: Clinical Data Management Oncology

Required Experience:

Director