Associate Director/Director, Scientific Data Lead
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Global Development Scientific Data Lead is a key contributor to the Global Development (GD) Systems team, responsible for ensuring the Scientific and Clinical data processes are efficient and effective from end-to-end. Identifies process improvements and enhancements to ensure accurate and timely data for Global Development Scientific, Clinical, Safety and Medical use. Work directly with senior management across multiple departments in Global Development to align strategy, define policies and communicate change management.
Essential Functions required for the job. List both technical and managerial requirements if applicable.
• Responsible for data curation to establish "single source of truth" for key Regeneron Scientific and Clinical data. This includes Clinical Trial data, Precision Medicine biomarker data, Safety data and Real World Evidence.
• Enable data dependent down-stream capabilities such as Medical Monitoring and cross-study analysis.
• Develop recommendations to reduce data redundancy and encourage appropriate data reuse by defining and managing authoritative sources of information.
• Develop and implement data standards, processes, procedures, and data governance for new systems and business processes. Implement processes related to cleansing, transforming, integrating and enriching data across Scientific and Clinical Data.
• Lead the design and delivery of scientific data exchange between Global Development and its strategic partners.
• Partner with members of Global Development, as well as external third parties, to continuously improve and validate data provided to our business partners.
• Develop and analyze metrics for data quality and data management processes.
• Ensure alignment to security and privacy requirements/standards
• Engage with the industry to learn about best practices to help in building excellence in Scientific and Clinical. In this capacity participate in industry groups and forums.
• Introduce and implement new innovative technologies to the business.
• To be determined based on experience and qualifications of applicant.
• BS/BA Degree with 15+ years relevant experience. MS degree and 12+ years relevant experience.
• Strong knowledge of industry data standards e.g. CDISC.
• Strong knowledge of tools for collecting and managing scientific and clinical data such as EDC (RAVE)
• Strong knowledge of data aggregation tools and capabilities.
• Demonstrated experience integrating data from multiple sources.
• Experience managing IT capability identification, selection and implementation .
• Good problem solving, technical writing and verbal communication skills
• Ability to effectively manage multiple priorities with a sense of urgency
• Attention to detail and accuracy of work
• Strong knowledge of SDLC methodologies and CFR Part 11 compliance
• Strong track record of project management, stakeholder management, budget management and collaboration skills
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.