Senior Director, Translational Medicine

Company: Novavax
Location: Gaithersburg
Posted on: September 18, 2020

Job Description:

Novavax, Inc.  (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax  is currently performing clinical trials of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and recently announced successful Phase 1 results. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.  Novavax  is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax is seeking a Senior Director, 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 immunologic 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 immunologic assays that are used in clinical studies are appropriate for agreed-upon endpoints and objectives of the study

Assure the analytic 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 immunologic approach and interpretation of results

Oversee vendor qualification, selection, and tech transfer of assays

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

Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Keywords: Novavax, Washington DC , Senior Director, Translational Medicine, Other , Gaithersburg, DC