What are the responsibilities and job description for the Associate Director, Translational Medicine position at Novavax, Inc.?
**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.
Novavax is seeking Associate Director in Translational Medicine to lead the translational medicine effort across our expanding portfolio of early and late-stage vaccine candidates. The Translational Medicine Lead will serve as the strategic and technical interface between clinical development team and both internal and external diagnostic and immunological laboratories.
Responsibilities include but are not limited to:
- Develop strategy to incorporate the most appropriate TM approaches into early and late stage clinical studies
- Define diagnostic approaches to be incorporated into vaccine studies and assure the outcome and analytic approaches are appropriate
- Define humoral, cellular and functional immunologic assays to be used in early and late stage clinical studies
- Interface between R&D and Clinical Immunology and external vendors to assure assays are fit-for-purpose and valid for their intended use
- Assure the diagnostic and immunological assays that are used in clinical studies are appropriate for agreed-upon endpoints and objectives of the study
- Assure the analytical approach, including data display, SAP, TLFs, are appropriate for the selected assays
- Author relevant sections of clinical, regulatory and peer-review documents
- Serve as the internal expert on translational medicine approach to be used in our vaccine studies
- Responsible for external communication of the diagnostic and immunological approach and interpretation of results
- Oversee vendor qualification, selection, and tech transfer of assays as needed
Minimum Requirements:
- Advanced degree (Doctorate, or similar degree) in Life Sciences, Biology, or similar discipline
- 7 years experience in infectious disease/vaccine development required with demonstrated experience with assays for diagnosing infectious diseases and measuring humoral, cellular and functional immune responses
- Demonstrated experience in communicating and working together collaboratively with key stakeholders in the disease community such as clinicians, researchers, and vendors
- Proven ability to thrive in a fast-paced, multidisciplinary environment while remaining flexible, creative, proactive, resourceful and efficient
- Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
- Excellent understanding of translational medicine, drug development and regulatory issues is desirable
- Diplomacy and professionalism, able to command respect from peers, and capable of highly independent work as well as being a team player and role model
- Excellent verbal and written communication skills, allowing for an open and effective dialogue throughout the company, and for effectively representing the company externally
- Strong problem-solving ability and attention to timelines, detail and quality are critical to success
- Highly motivated and results-oriented individual with the flexibility and creativity to excel in and contribute to multiple projects simultaneously in a rapidly growing company
- Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs
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.
