Associate Director - Data Management Operations - Solid Tumor or Hematology (Hybrid)

AbbVie Inc.

Job Overview

Location

Remote

Job Type

Full-time

Full Job Description

📋 Description

• Lead the end-to-end data management operations for global Phase I-III oncology trials in either solid tumor or hematology indications, ensuring the integrity, quality, and timely delivery of clinical data that directly influences life-saving treatment decisions.
• Serve as the strategic data steward for cross-functional study teams, translating complex scientific questions into robust data collection strategies, standards, and specifications that accelerate the development of next-generation cancer therapies.
• Own the design, validation, and maintenance of clinical databases (EDC), ensuring compliance with CDISC SDTM/ADaM, 21 CFR Part 11, and global regulatory requirements while driving continuous process improvement to reduce cycle times by up to 20%.
• Direct a high-performing matrix team of 8-12 data managers, programmers, and vendors across North America, Europe, and APAC, fostering a culture of scientific rigor, operational excellence, and inclusive leadership that has earned AbbVie a top-tier employer reputation.
• Partner with Biostatistics, Clinical Operations, Regulatory, and Medical Affairs to align data strategies with evolving protocol amendments, competitive intelligence, and regulatory feedback, ensuring seamless integration from first-in-human studies through post-marketing commitments.
• Champion innovative data technologies—such as synthetic control arms, real-world evidence integration, and decentralized trial platforms—to expand patient access and generate richer evidence sets, positioning AbbVie as an industry pioneer in oncology R&D.
• Oversee vendor selection, contracting, and performance management for global CROs and specialty data providers, negotiating service-level agreements that safeguard data quality while achieving cost efficiencies exceeding $2 M annually.
• Establish and monitor key performance indicators (KPIs) for data quality, timeliness, and compliance, presenting quarterly dashboards to executive leadership that inform portfolio-level risk assessments and resource allocation decisions.
• Drive inspection readiness by leading regulatory authority interactions (FDA, EMA, PMDA), authoring data management sections of IND/BLA submissions, and ensuring zero-critical findings during health authority audits across 50+ studies.
• Mentor and develop emerging talent through AbbVie’s Oncology Leadership Development Program, delivering tailored coaching that has advanced 75% of direct reports into director-level roles within three years.
• Collaborate with Patient Advocacy and Diversity & Inclusion teams to embed equitable data practices, ensuring clinical datasets accurately reflect real-world demographics and support label expansions in underserved populations.
• Spearhead post-hoc analyses and exploratory data science initiatives that unlock novel biomarker insights, contributing to 10+ peer-reviewed publications annually and reinforcing AbbVie’s reputation as a scientific thought leader.
• Leverage agile project management methodologies to adapt rapidly to shifting priorities, maintaining a 95% on-time delivery rate for database lock milestones across a dynamic portfolio of 30+ concurrent studies.

🎯 Requirements

• Bachelor’s or advanced degree in life sciences, data science, or related field with 10+ years of progressive data management leadership in oncology clinical trials, including 5+ years managing global Phase III programs.
• Demonstrated expertise in CDISC SDTM/ADaM standards, EDC platforms (Medidata Rave, Veeva Vault EDC), and regulatory submissions (IND/BLA/NDA) with a track record of successful health authority interactions.
• Proven ability to lead distributed teams across multiple time zones and cultures, with strong stakeholder management skills and fluency in English (additional languages a plus).
• Deep therapeutic knowledge in either solid tumor (e.g., lung, breast, colorectal) or hematologic malignancies (e.g., lymphoma, leukemia, myeloma) with familiarity in novel endpoints and precision medicine trial designs.
• Nice-to-have: Advanced certification (PMP, CCDM, Lean Six Sigma), experience with decentralized/virtual trials, and proficiency in SQL/R/Python for exploratory data analysis.

🏖️ Benefits

• Hybrid work model (3 days remote, 2 days on-site in North Chicago or optional Boston/San Francisco hubs) with full home-office setup stipend and flexible scheduling.
• Comprehensive total rewards package including 18% annual bonus target, long-term incentives (RSUs), and 401(k) match up to 6% with immediate vesting.
• World-class health and wellness benefits (medical, dental, vision from day one), on-site fitness centers, and up to 12 weeks of paid parental leave for all caregivers.
• Annual professional development budget of $10,000 for conferences, certifications, and advanced education, plus 4 weeks of paid sabbatical every 5 years.

Skills & Technologies

Junior

Remote

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AbbVie Inc.

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About AbbVie Inc.

AbbVie is a global biopharmaceutical company that discovers, develops, manufactures, and markets advanced therapies and medicines. Its portfolio spans immunology, oncology, neuroscience, eye care, and other serious health conditions. The company invests heavily in research and development to address unmet medical needs worldwide.

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