Director/Associate Director, Clinical Development

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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.

We are seeking an MD to join Clinical Development group for the Corona Vaccine Program.   The incumbent will be primarily responsible for supporting the clinical trial program including protocol development and medical oversight of ongoing studies.  He/she will be responsible for work with other clinical Development physicians, biostatisticians for trial design and analyses, contribute to regulatory submissions, and for working closely with operations to learn and ensure medical input to achieve operational excellence.  The candidate must have strong collaborative interpersonal skills and medical insight across the scope of the vaccine and infectious diseases therapeutic area.  Prior experience in a pharmaceutical or biotech environment may be beneficial but is not required. This role will be working on product development in an extremely fast paced and intense environment, so motivation, agility, resilience and passion for the goal of the development will be required. 

 

The position will be located either at Gaithersburg MD or remote, but with an expectation of at least one week per month to be at the corporate center (in addition to travel requirements).  International travel may be involved.   

 

Responsibilities include but are not limited to:

 

  • Collaborate with Leaders of clinical development on strategy
  • With oversight, direct human clinical trials, phases I-IV, for lead candidate in development, helping to ensure all clinical development milestones are met
  • Participate in collaborative medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals
  • Collaborate on reports submitted to FDA, CDC, WHO, or other government, regulatory, or partner agencies
  • Presentations, as appropriate, to various external stakeholders - regulators, principle investigators, scientific conference attendees, advisors and opinion leaders
  • Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols and safety reviews
  • Contributing to Clinical Study Reports
  • Other duties as assigned

 

Minimum requirements:

 

  • MD with post-doctoral vaccine or infectious diseases specialty training or experience
  • Two – 5 years experience in a research environment involving the collection and analysis of human data in the area of infectious diseases
  • Functional knowledge of concepts in vaccine immunology, preferably with experience in design and conduct of clinical trials
  • Self-starter who will move forward assigned projects with reasonable guidance and oversight, able to manage multiple independent tasks needed to support the clinical development program
  • Experience to assess safety as a physician in either practice or clinical development
  • Skillsets to develop effective leadership skills
  • Excellent verbal and written communication skills
  • Ability to work cross-functionally

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.

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. 

#LI-JW #LI-remote  

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job details
Clinical
Remote - US
USA
SENIO003472
Full-time