Director, Risk Management

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.

Summary of the Position: 

The Director, Risk Management, Global Vaccine Safety is responsible for providing pharmacovigilance risk management functional area expertise and support to project teams assigned to developmental and/or marketed products. This includes leading the cross-functional assessment of the benefit- risk profile, defining risk management strategies, and communicating safety information to internal and external stakeholders. This position will support all aspects of the Novavax risk management system. 

Responsibilities include but are not limited to: 

• Leads the development and execution of risk management plans (RMPs) globally
• Authoring Risk Management Plans (RMPs), e.g., EU RMPs, UK specific RMP Annex, Canadian RMP Addendum, US Pharmacovigilance Plan, and other country-specific risk management documents
• Oversees the implementation of risk management commitments globally according to RMPs
• Provides risk management expertise (e.g., regulations, processes, principles, methods, tools, best practices) to cross-functional teams
• Oversees compliance with risk management post-marketing commitments and provides status reports
• Actively participates in inspections and audits related to RMPs and risk management commitments
• Leads risk management projects, including project planning, budgets, vendors, communication, etc.
• Oversees the monitoring/tracking of additional PV (e.g., PASS, PAES) and/or additional risk minimization measures using designated tracking tools
• Leads cross-functional risk management team meetings and communications, including safety, regulatory, clinical, medical affairs, etc.
• Develops training programs on implementation of risk management activities
• Liaises with Qualified Person for Pharmacovigilance (QPPV) and/or Local Safety Officers to implement risk management activities locally, as needed
• Escalates risk management issues to Global Vaccine Safety Leadership, as needed

Minimum Requirements: 

• PharmD/PhD in relevant scientific discipline with 8+ years’ experience in Safety and Pharmacovigilance working in a biotechnology or pharmaceutical company
• Masters with 13+ years’ experience or Bachelor’s degree with 16+ years’ experience. PharmD/MSc/PhD in scientific field preferred
• In-depth knowledge of clinical trial and post-authorization pharmacovigilance methodology, pharmacovigilance regulations, safety data analysis and benefit-risk assessment, and understanding of drug development.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
• Experience in the preparation and authoring risk management plans as well as other clinical/regulatory documents
• Working knowledge of MedDRA

Preferred Qualifications: 

• Experience in global pharmaceutical/biotechnology company, with special reference to vaccines and/or immunotherapeutics, and preparation of risk management plans and other company core safety documents
• Proven experience working in/leading (safety &/or scientific) pre- and post-authorization risk management programs
• Strong attention to detail and persistence in following tasks through to completion
• Proficiency with standard office software (Microsoft Office)
• Good organizational and prioritization skills
• Good interpersonal skills (i.e. team player)
• Ability to work independently
• Flexibility and ability to adapt and learn quickly
• Ability to work under pressure and to tight deadlines
• Excellent communication and presentation skills in English (both written and spoken)

Every day our employees impact the future of health by preventing disease. To recognize their contributions, we offer them performance-based pay; a flexible, welcoming work environment; comprehensive and competitive benefits.  

Novavax is headquartered in Gaithersburg, Maryland. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease. 

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals 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 protected characteristic.