Associate Director, Risk Management


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

**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 promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

The Associate Director, Risk Management will be responsible for providing pharmacovigilance functional area expertise and support to project teams assigned to developmental and/or marketed products. This includes participating in safety review activities, managing the cross-functional assessment of the benefit-risk profile and, communication of safety information to internal and external stakeholders. This position will generate or provide input to safety documents and reports to be submitted to regulatory authorities.  

This position will report to the Sr. Director, Pharmacovigilance Risk Management.

Responsibilities include but are not limited to:

  • Participates in the development and execution of risk management plans (RMPs) globally
  • Ensures 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
  • Measures compliance with risk management post-marketing commitments and provides status reports
  • Supports inspections and audits related to RMPs and risk management commitments
  • Manages risk management projects, including project planning, budgets, vendors, communication, etc.
  • Monitors/track implementation of additional PV (e.g., PASS, PAES) and/or additional risk minimization activities using designated tracking tools
  • Schedules and facilitates cross-functional risk management team meetings and communications, including safety, regulatory, clinical, medical affairs, etc.
  • Delivers 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 Safety Leadership, as needed 

Minimum Requirements:

  • PharmD/PhD in relevant scientific discipline with 5+ years’ experience in Safety and Pharmacovigilance working on global clinical trials in a biotechnology or pharmaceutical company
  • Masters with 10+ years’ experience or Bachelor’s degree with 13+ years’ experience
  • PharmD/MSc/PhD in scientific field preferred
  • 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

Additional Desirable Skills

  • 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) 

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

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.

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