Dir Local Lab Delivery & Standards

Regeneron Pharmaceuticals • Village of Tarrytown, NY

17h • Onsite

About The Position

The Director, Clinical Data Standards and Laboratory Data Delivery is an integral leader of the Data Management Central Services group and will be responsible for setting the vision and strategy for the Clinical Data Standards and Laboratory Data Delivery groups. This role focuses on the development, implementation and governance of global standards for participant-level data as well as delivery of clinical laboratory data services in support of Regeneron’s clinical pipeline. The incumbent will be accountable for end-to-end Clinical Data Standards Governance process framework to ensure proper utilization of and adherence to the established data standards. Responsibilities include thorough assessment of standards libraries and enhancements, chairing Standards Committee meetings and ongoing management of change requests as well as the roll out of cross-functional training to increase knowledge and awareness of Regeneron’s data standards. Additionally, the Director will be responsible for the optimization of laboratory data collection, validation and delivery across the portfolio along with the corresponding technology solutions. This position emphasizes cross-functional collaboration with internal and external stakeholders, advanced knowledge of various therapeutic areas and deep expertise in all standard library components and metadata across data collection, analysis and reporting continuum.

Requirements

• Expertise in developing clinical data standards libraries for multiple indications across various therapeutic areas, e.g. Oncology, Hematology, Immunology, Internal Medicine, etc.
• 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, related to data acquisition, processing, handling and reporting used in drug development.
• Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry standards.
• Demonstrated success in solving complex business problems, strategic thinking, leading through periods of significant change, i.e., operating model shifts, dynamic portfolio expansion, company and/or asset acquisitions.
• Ability to build relationships and gain consensus with key internal and external stakeholders at study team and leadership levels by negotiating effectively and collaborating successfully.
• Proven ability to establish highly motivated and performing teams with a focus on transformation, innovation and operational excellence.
• 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.
• Minimum of 12+ years in External Clinical Data Management with expert strong knowledge of database structures within the biotechnology, pharmaceutical or health related industry.
• Minimum of 5 years of people manager experience required.
• Bachelor’s degree in a Science, Health, Computing, or related field.

Nice To Haves

• CDISC Standards Certification a plus

Responsibilities

• 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 (CDASH, SDTM, etc.), ensuring consistency in integration, regulatory compliance, and interoperability across studies and therapeutic area(s).
• Lead the evaluation, design and implementation of metadata repository (MDR) and the corresponding process framework to centrally manage controlled terminology, Case Report Forms (CRF), edit checks and data validation outputs libraries.
• Chair the Data Standards Committee meetings and effectively manage change requests (CRs) to ensure short turn around time cycles; contribute to digital protocol & metadata driven study design enablement; enhance and expand Regeneron’s Clinical Data Standards Libraries via quarterly standard package releases.
• Establish process framework and technology solutions for accurate and efficient laboratory data collection, automated/AI-enabled validation and reporting of laboratory data across studies and programs.
• Govern and maintain Regeneron’s Global Standard Analyte Library, Laboratory Normal Range (LNR) template and standardized textbook ranges library as well as standard units of measure, and conversion algorithms ensuring consistent application across the portfolio.
• Collaborate with external laboratory vendors to standardize the set up of laboratory data collection systems and standard Data Transfer Specifications (DTS) to ensure timely availability of quality, fit-for-purpose laboratory data.
• Provide expert level guidance to study team members on development of appropriate study-level lab eCRFs, CRF Completion Guidelines (CCGs), edit checks and resolution of issues related to laboratory data.
• Liaise with internal and external stakeholders to foster strong relationships and ensure effective cross-functional collaboration and communication with respect to deliverables and throughout drug development process.
• Responsible for selection and recruitment of top industry talent for the Data Standards and Laboratory Data Delivery team; provide constructive performance appraisals to ensure professional growth and development.
• Author and contribute to the development of global clinical data management SOPs/WIs related to standards management process and laboratory data management along with the corresponding departmental training curricula.
• Demonstrate company values and act as a role model by promoting competence, collaboration, innovation, respect, ownership and accountability.
• Maintain awareness of clinical data standards emerging trends, laboratory data management technology solutions and industry best practices through peer relationships with thought leaders in the industry and contributions to professional organizations, such as CDISC; represent Regeneron in professional associations and forums.

Benefits

• comprehensive benefits, which vary by location
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Director