Accountable for setting the vision, strategy, and goals for Clinical Data Standards and Laboratory Data Delivery Teams
Responsible for the development, management and governance of clinical data standards in alignment with the CDISC requirements
Lead the evaluation, design and implementation of metadata repository (MDR) and the corresponding process framework
Chair the Data Standards Committee meetings and effectively manage change requests (CRs)
Establish process framework and technology solutions for accurate and efficient laboratory data collection
Govern and maintain Regeneron’s Global Standard Analyte Library
Collaborate with external laboratory vendors to standardize the set up of laboratory data collection systems
Provide expert level guidance to study team members
Liaise with internal and external stakeholders to foster strong relationships
Responsible for selection and recruitment of top industry talent for the Data Standards and Laboratory Data Delivery team
Author and contribute to the development of global clinical data management SOPs/WIs

Minimum of 12+ years in External Clinical Data Management
CDISC Standards Certification a plus
Minimum of 5 years of people manager experience required
Expertise in developing clinical data standards libraries for multiple indications across various therapeutic areas
Technical skills related to clinical laboratory data science and laboratory data management
Advanced knowledge of clinical data management principles, technologies, regulations and best practices, including CDISC, 21 CFR Part 11, ICH-GCP Guidelines, GxP compliance and GDPR
Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry standards
Demonstrated success in solving complex business problems
Ability to build relationships and gain consensus with key internal and external stakeholders
Proven ability to establish highly motivated and performing teams
Strong understanding of cross-functional activities and management of multiple and varied tasks with enthusiasm and attention to detail
Excellent interpersonal, oral, and written communication skills
Ability to adjust in a fast-paced environment.

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
paid leaves (e.g., military and parental leave) for eligible employees

Director, Local Lab Delivery & Standards

Key skills