Senior Director, Clinical Data Operations

The Senior Director of Clinical Data Operations is a key contributor to the operational vision, direction and strategy for the Data Management line function globally in support of the clinical pipeline. This includes, but is not limited to, development and implementation of innovative process frameworks and technology solutions aimed at enabling new and enhanced data management capabilities, improved operational efficiencies, increased productivity, and regulatory compliance as related to data standards, quality and integrity during data capture, validation and reporting.

As a Senior Director, the incumbent will collaborate cross-functionally with internal stakeholders and external vendors to provide strategic direction and technical expertise to advance internal clinical data management capabilities through innovative platforms and technologies that enhance the design, integrity and lifecycle of clinical databases, streamline external data integrations and improve data availability and quality to accelerate clinical data insights and decision making. The Senior Director of Clinical Data Operations is essential to building and leading a high-performing Data Operations group to support the Data Management line function.

• Establish and implement the global strategy and delivery roadmap for clinical data operations group to enhance internal capabilities in database development, data standards and governance, analytics and reporting, and external data integrations using innovative platforms and technologies.

• Lead strategic assessment and implementation of clinical technologies – scoping industry trends, evaluating innovative platforms and overseeing vendor selection and qualification through enterprise adoption.

• Drive optimization of technology, systems and processes and data standards focusing on decreased cycle times, improved quality and inspection readiness as related to participant-level external data acquisition, processing and delivery, including graphical representation of metrics and analytics and quality control processes for acceptance of data from external vendors.

• Accountable for delivery, administration and routine maintenance of the Clinical Scientific Data Lake and related business tools ensuring maximum up time and compliance with regulatory requirements.

• Champion the use of automation to reduce manual data handling and processing and enable faster data accessibility and workflow efficiencies.

• Liaise with internal and external stakeholders to foster positive relationships and ensure effective cross-functional collaboration and communication throughout drug development process.

• Provide vendor and external partner oversight to ensure the systems, processes and procedures used during participant-level data acquisition, transmission and storage conform with the established Regeneron standards and are of high quality and compliant with 21 CFR Part 11, GxP-, GDPR- and study requirements.

• Proactively identify and propose solutions to mitigate risks for the function globally, ensuring support for critical study data management milestones.

• Responsible for line management and performance of Data Operations staff, mentorships of associates, development of competencies and assessment of annual performance.

• Contribute to annual resource planning and ongoing resource allocations; accountable for assessment of candidates and hiring top industry talent.

• Author and contribute to the development of global clinical data management system SOPs, WIs and BPTs and departmental training curricula.

• Maintain awareness of Data Management emerging trends, technology solutions and industry innovations through peer relationships with thought leaders in the industry; represent Regeneron in professional associations and forums.

To be considered for this role, you must meet the following qualifications:

• Leadership experience in Clinical Data Operations or related field, leading small to medium functional groups supporting global data management line function.

• Expertise in clinical data technologies (cloud ecosystems, systems architecture, data integrations, business intelligence solutions) and clinical data systems (EDC, eSource, eCOA, IRT, Clinical Data Repository/data lakes).

• Ability to identify and evaluate business cases through proof-of-concept (POC) initiatives and deploy transforming concepts into scalable technical solutions to address operational challenges, increase efficiency and enhance business capabilities.

• Advanced knowledge of clinical data management principles, technologies, regulations and best practices, including 21 CFR Part 11, ICH-GCP Guidelines, GxP compliance and GDPR, related to data acquisition, processing, handling