Senior Director/Director, Data Management

Company: Novavax
Location: Gaithersburg
Posted on: January 14, 2021

Job Description:

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.The Sr. Director / Director of Data Management is responsible delivery of global data management strategy and overseeing end to end data management activities and deliverables of our vendor partners across multiple programs. You are responsible for leading vendor oversight of clinical data management in the areas of project management, data systems and quality, and is accountable for the implementation of data strategy to ensure outsourced data management activities are performed in compliance with regulations, according to study protocol, and the clinical data management plan. You will be the key point person and primary point of escalation for internal teams of Medical, Clinical Project Management, Biostatistics and Programming, Project Management, Quality Assurance, and Regulatory Affairs. This position will report to the Vice President, Clinical Operations. Responsibilities include but are not limited to:Leadership of all data management activities including deliverables for the build, collection, review, monitoring of clinical data including CRF data, ePRO, and internal and external laboratory data to ensure that studies are executed within the agreed timelines and according to applicable SOPs, global standards, and working practices. Development and management of a resource plan to ensure Data Management is able to deliver the business portfolio, including Data Acquisition, Data Standards & SDTM Delivery and functional service providers.Accountable for the implementation of data strategy at a program and study level, monitoring, and timeliness of data processing performed by the CRO from start up through data archival including activities related to cleaning, acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting.Develops quality oversight and management standards of external partners (e.g. CROs, technology providers, etc.) who are performing data management services for Novavax, and leads and manages Sponsor oversight of data reports, metrics, and key performance indicators (KPIs) to monitor vendor performance and proactively provides risk and mitigation feedback directly to vendor. Drives functional line RFP assessment, budget review, and invoice approval standard practices. Line management, coach, and support data management staff. Identify, lead and drive process improvements within the DM community.Reviews the Data Management Plan (and other data related plans, risk registers, and documents) to ensure consistency within a program, oversees interim and final cleaned database freeze and release strategy and timeliness; and regulatory submission related activities. Foster relationship with Medical, Biostatistics, and Programming teams understand data delivery for business needs and priorities.Point of escalation for all data management study issues. Other duties as assigned.Minimum Requirements:Bachelor's degree minimum requirement and 12 years of relevant data management experience in biotechnology, pharmaceutical or CRO settings. Global clinical trial and vaccine therapeutic experience highly desiredProficient experience using commercial clinical data management systems and/or EDC products (e.g. RAVE EDC). Proficient with implementation and data transfer of external data to clinical database (e.g., external laboratory and Electronic Patient Reported Outcomes (ePRO) data and eSource).Data visualization tools (e.g. Spotfire, J-Review) and MedDRA/WHO-Drug coding expert.Proficiency in SQL and scripting with experience in developing advanced queries, stored procedures and views. SAS programming is a plus. Proficient in development and maintenance of the Data Management Plan, data review and query management, data access and visualization, metrics reporting, external data transfer into clinical database, and database release activities. Experienced with data reconciliations between clinical database and other databases (e.g. Product Safety and LIMS)Solid understanding of statistical outputs (tables, listings and graphs) to ensure data review reports match program and study needs.Understanding of regulatory requirements for license applications with US FDA and other regulatory agenciesFluent with CDISC requirements including CDASH, SDTM, and ADAM.Additional Qualifications / Experience Preferred:Interface with external vendors developing systems/applications for clinical trial data collection (e.g. ePRO/eCOA) to ensure quality and timely deployment.Experience in developing the tools/reports to support CRO oversight activities.Demonstrates strong verbal and written communication skills including ability to communicate remotely.Detail oriented, ability to multi-task with strong prioritization, planning and organization skills Good written and spoken EnglishWillingness to travel for job related activities if required (expected travel for this position is

Keywords: Novavax, Washington DC , Senior Director/Director, Data Management, Executive , Gaithersburg, DC