**Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.**
If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
This position reports to the Executive Director, Clinical Vendor Outsourcing and Business Operations, and collaborates with Clinical Operations, Global Project Management, Global Clinical Compliance and IT, as well as other cross-functional teams as needed to provide management support and guidance regarding business processes and systems in Clinical Operations.
The Associate Director, Business Operations will create strategic and transitional plans to support effective business processes and clinical systems for Novavax Clinical Operations. The positions will be responsible for the development of a strategic direction for technology development and implementation to drive efficiencies. This individual will also highlight clinical informatics opportunities and requirements for global clinical trial operations and resolution of outstanding issues.
The Associate Director, Business Operations will be the business owner for clinical systems supporting Clinical Operations, provide expertise in computerized platforms and maintain necessary certifications (currently, Veeva certification). Solid understanding standardization of data and processes relating to the conduct of clinical trials in the biotech and vaccine sectors. Good understanding of contemporary information management, health and business processes, technologies and applications and their application in solving complex business and operational challenges.
Essential functions of the job include but are not limited to:
- Identify new process improvement opportunities. Leverage clinical systems data to improve transparency, efficiency, and compliance in Clinical Operations. Ensure Novavax study management process is well supported by clinical systems and aligned with business requirements.
- Ensure alignment and consistency of study timelines and milestones between Clinical Operations, Global Project Management and CROs.
- Ensure SOPs and guidance documents related to the use of clinical systems, including its integration with other business systems appropriately supports Novavax study management processes.
- Develop and maintain a 3-5-year Strategic Roadmap outlining the timing and sequencing for delivering key business capabilities (new systems) and enhancements to the existing systems to support business needs over the long term.
- Create and implement change management strategies and plans that maximize employee adoption and usage and minimize resistance.
- Act as the Business Owner for clinical systems and liaise with Subject Matter Experts, Novavax IT, external vendors and Global Project Management teams to ensure proper alignment and integration support of clinical systems either Novavax or CRO systems.
- Ensure that: (a) implementation timeline of new functionality is in alignment with clinical roadmap and operating model, and (b) there is optimal transition in each phase from implementation to operations.
- Partner with Global Project Management to ensure consistency between Veeva and MS Project
- Work with stakeholders to support the business requirements
- Lead the clinical systems information analytics to support Novavax study metrics analysis. Engage cross functional teams to support the use of Novavax Clinical Dashboards and reports. Lead performance metrics, KPIs, SLAs reviews, identifying trends and escalating any existing or projected study/program/portfolio risks to appropriate leads.
- Lead CTMS Data Standards to ensure streamlined data entry and workflows supporting business requirements of stakeholders. Oversee quality control functions of data requirements and escalate ongoing compliance issues to Executive Sponsors as appropriate.
- Manage end user system support functions according to service level agreements, including: facilitation of user access process, triaging end user workflow/data entry issues
- Partner with IT for the technical management and support of the CTMS. Work in partnership to plan for technical maintenance and upgrades and assure business impacts are assessed and communicated to appropriate stakeholders.
- Oversee and integrate the CTMS Implementation Plan into the operating model and budget, preparing for optimal operationalization of capabilities as it is delivered by the implementation team over a multi-year period.
- Bachelor’s Degree
- 10+ years of biotech, pharma and/or CRO experience, includes relevant experience in clinical systems, including CTMS (Veeva preferred) and/or clinical project management.
- Demonstrated strong governance management in a fast paced matrixed setting, including the abilities to inform strategic decisions, to facilitate and negotiate through complex strategic decisions, to communicate with executive leadership, and lead through influence within matrix teams.
- Solid foundation in data governance principles and experience managing large data sets.
- Proficient in MS Office suite
- Working knowledge of ICH-GCP guidelines and major Health Authority regulations
- Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
- Working knowledge of clinical operations workflows; some knowledge of study management and reporting needs.
- Proven ability to collaborate in a team environment and work independently
- Excellent oral and written communication skills
- Must be a team-player, reliable, dependable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
- Proven ability to establish productive working relationships across large organizations, communicate well at all levels, and to work collaboratively to build strong partnerships.
- Working knowledge of and experience with Medidata Rave EDC, preferably Medidata Rave
- Experience collaborating and working with vendors, including CROs, Labs, software and consulting services.
- Understanding of Quality management system (including computer system validation practices)
- Veeva Vault Certified
- Some experience with Adobe Acrobat, creation and development of editable/fillable Adobe forms
- MS project or other GANTT charting and milestone development is a plus
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.