Associate Director, Strategic Planning and Data Operations
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 . Summary . Supports the Data Management leaders to ensure the Data Management function achieves operational deliverables, reports out metrics to monitor for areas of risk for TA and by CRO, collate and perform an impact analysis for each proposed process improvement, serves as the primary contact to communicate DM practices with CROs and neighboring functions for process changes/updates, and drives overall project management of Data Operations and DM TA Head group initiatives . Job Duties . Champion the development of processes for outsourced and FSP SOPs, technical manuals, and other communications . Oversee the development, coordination, and maintenance of training courses for the DM activities and technologies used . Lead the development and reporting of metrics for the Data Management, working with the DM Head sponsor , CPMO Analytics team, and technical teams . Develop planning and resource management tools, and performance metrics to achieve excellence in Data Management outputs . Provide project management support for continuous improvement initiatives with DM Process Improvement and Knowledge Management, and the CPMO Processes and Procedures group support . Contribute to the strategy of the Data Management function as a DMLT member . Facilitate open communication within DM groups TA Heads of CDM, Database Development, and External Clinical Data Integration, Inspection Readiness and CAPA Management, and DM Process Control and Knowledge Management , serving as a conduit to provide information about DM needs . Participates in FSP selection and performance management to control expenditure . Adheres to procedures surrounding retention of data, records, and information for clinical studies . May provide Subject Matter Expert Support for select topics assigned . Requirements . Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. Must have least 10 or more years of clinical data management experience and 15 or more years experience in biotechnology, pharmaceutical or health related industry. Previous oncology experience a plus . Self directed and comfortable working in cross-functional teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required. Familiarity with all applicable regulations including . CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt skills. Strong written and oral communication skills required . At least 5 years of project team leadership experience. Familiar with appropriate EDC applications, prevalent vendor data systems of labs, eCOA/ePRO, and local lab information. Additionally, Microsoft Office applications . May manage up to 3+ individuals a matrix environment. Strong coaching and training skills - team player. May report to Senior Director or above . 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.