Assoc Dir Clinical Data Operations

Regeneron Pharmaceuticals • Warren, MI

2d

About The Position

SUMMARY The Associate Director of Clinical Data Operations supports the strategic vision and execution of clinical data operations initiatives by overseeing components of clinical data lake, clinical data management reporting, analytics & visualizations, and workflow automation. This role contributes to developing innovative, efficient, and regulatory compliant data solutions to advance departmental objectives, enhance business capabilities, and enable high-quality clinical data for downstream activities. The Associate Director, Clinical Data Operations drives operational leadership and managerial oversight across clinical data lake processes, data reporting, and analytics workflows to ensure consistent, high-quality execution and team performance. Core responsibilities include the design, implementation, and management of data lake solutions, as well as developing and implementing clinical data models that standardize and integrate datasets in conformance with industry standards such as CDISC (SDTM, ADaM), and global regulations. This role also supports participant-level data governance practices, process optimization, and workflow automation, in adherence to clinical data management standards, GxP and regulatory requirements to ensure data integrity, improve quality, and enhance operational efficiencies. Through close collaboration with IT and Global business teams, the role ensures that the data lake solutions are designed and operated to effectively support departmental objectives, advanced analytics capabilities, and data-driven decision making. The role also leverages clinical data models to strengthen the standardization, integration, and interoperability of diverse clinical datasets.

Requirements

• 10+ years of experience in data management, data engineering, or clinical operations, with at least 5 years in a leadership role.
• Experience managing large-scale data lake solutions, preferably in the healthcare or clinical research domain.
• Strong understanding of clinical trial processes, data standards (CDISC, SDTM, ADaM), and regulatory requirements.
• Expertise in big data technologies such as Spark, AWS, or Google Cloud.
• Proficient in clinical data integration and workflow automation, with strong capabilities in analytics, reporting, and visualization tools.
• Proficient in database management (SQL, NoSQL) and ETL tools.
• Deep understanding of scientific and clinical data collection and management platforms, including EDC, Real World Evidence, Biomarker, and other external data.
• Strong knowledge of data aggregation tools and the ability to translate findings into actionable insights that drive downstream operational activities.
• Proven ability to integrate data from diverse sources, ensuring seamless data flow, consistency, and reliability across operational and analytical environments.
• Ability to analyze and resolve complex clinical data systems and integration challenges with scalable and sustainable solutions.
• Strong analytical, problem-solving, project management, and stakeholder management skills.

Responsibilities

• Implement the vision and strategy for the Clinical Data Lake, ensuring alignment with departmental objectives and adherence to Good Clinical Practice (GCP) principles.
• Collaborate with business stakeholders and systems teams to understand clinical research needs and establish a comprehensive data lake solutions roadmap, prioritizing high-value capabilities.
• Oversee the design, development, and implementation of the Clinical Data Lake, ensuring seamless integration with existing systems and processes.
• Lead the design and implementation of standardized data models to harmonize and integrate data for analytics and reporting.
• Lead efforts to build and maintain robust data pipelines from diverse sources including EDC systems, vendor labs, Biomarker data, electronic health records (EHR), and other healthcare datasets.
• Drive strategies for advanced data capabilities, including analytical layers and visualization tools to support clinical decision-making.
• Ensure the security, privacy, and compliance of clinical data by implementing robust access controls, encryption protocols, and audit trials in alignment with global regulatory standards such as GDPR, HIPAA, and ICH-GCP.
• Ensure alignment of clinical data structures and deliverables with CDISC standards (SDTM, ADaM) and maintain compliance with global regulatory requirements.
• Develop and maintain metadata management practices and data lineage tracking to ensure data integrity and transparency.
• Maintain inspection readiness of the Clinical Data Lake solutions by maintaining robust operational controls, documentation, and consistent adherence to GxP regulations across all clinical data workflows.
• Partner with other data lake initiatives to promote efficient operating models, domain sharing, and reuse of data assets to minimize redundancy.
• Direct and develop team members through clear expectations, performance management, and disciplined execution across all operational workflows.
• Manage matrixed teams focused on data ingestion, quality, transformation, standardization, and visualization to deliver high-value data solutions.
• Stay updated with emerging technologies, best practices, and regulatory changes in clinical data management to ensure organizational innovation.

Benefits

• We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed