Novavax
  • 07-Jun-2021 to 06-Jul-2021 (EST)
  • Clinical Development
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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.

We are seeking a motivated and experienced Clinical Trial Supply Manager to manage all aspects of supplies for clinical studies, including investigational product (IP). The ideal candidate will have strong analytical, organizational, communication, networking, and team skills, and will demonstrate a proven ability to take initiative and manage multiple tasks in a fast-paced environment. This position will be part of the Clinical Operations team and report to the Senior Clinical Trial Supply Manager.

This position is fully remote.

Responsibilities include but are not limited to:

  • Working with study teams to plan and manage investigational drug and ancillary supplies for clinical study sites including
    • Performing product inventory checks and maintaining proper inventory levels needed for clinical trials at site and depot levels
    • Oversee procuring concomitant and comparator drugs for clinical trials as needed
    • Coordinating/Facilitating distribution of investigational drug and ancillary supplies
    • Tracking all investigational product and ancillary shipments to and from all clinical sites
    • Facilitating import and export documents such as: Import License, special permits, Proforma Invoice, and additional documentation required to transport clinical trial material (CTM) to its final destination.
    • Monitoring all packaging and labeling activities as well as ensuring proper storage for all investigational product at depots and sites
    • Reviewing and approving clinical supply packaging and labeling records, reviewing Clinical Trial Supplies sections of all relevant clinical documents
    • Authoring/reviewing label text and label design for investigational drugs used in clinical trials while maintaining proper regulatory and quality standards
    • Tracking expiry dates, and initiating extension of re-labeling of investigational product at distribution center and at the site
    • Overseeing packaging and labeling operations at clinical supply vendors
    • Coordinating returns and destruction of investigational product at sites and depots.
    • Create and maintain study specific Pharmacy Manual
    • Reviewing CRO/vendor proposals and contracts for packaging/labeling/distribution of investigational product
  • Input to forecasting clinical supply needs for domestic and global clinical trials.

Minimum requirements:

  • BS, BA or equivalent in life sciences or health-related field
  • Minimum of 5 years relevant (e.g., clinical, pharmaceutics, clinical trial material) pharmaceutical/biotechnology experience
  • Experience with investigational drug product primary/secondary packaging and labeling processes
  • Experience with labeling, distribution, and recall processes for investigational products
  • Experience with set up of IRT systems to manage supply distribution and resupply
  • Clinical study site interaction skills; previous training in GMP/GCP optimal
  • Contracts and vendor management experience
  • Detail orientated and process focused
  • Excellent communication (written and oral) and interpersonal skills
  • Work effectively with team members across all levels of the organization
  • Able to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines

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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