Associate Director, Safety Epidemiology and Benefit Risk


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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 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.

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

Summary of the Position:

The Associate Director, Safety Surveillance, Global Vaccine Safety will be responsible for providing epidemiology/pharmacoepidemiology functional area expertise and support to project teams assigned to developmental and/or marketed products.

Responsibilities include but are not limited to:

  • Overall responsibility for the planning, design, conduct, and analysis of regulatory-grade epidemiologic post-marketing safety and/or effectiveness research studies, and real-world evidence (RWE) signal evaluation
  • As needed, assist with observed versus expected analyses, develop epidemiological insight for the reporting and outcomes from VAERS, EudraVigilance and other global spontaneous reporting databases
  • Identification of relevant real world data sources / assets to characterize disease natural history and contextualize vaccine safety by utilizing background rates and/or external comparator cohorts
  • Develop primary subject matter expertise in one or more infectious disease areas
  • Assist with developing epidemiologic research plans and results internally; to external agencies and health authorities such as FDA, EMA, CDC, and WHO
  • Contract and manage vendors and/or consultants to meet the epidemiology and benefit risk analysis needs of Novavax.
  • Maintain close working relationships with Novavax development teams in the areas of Global Vaccine Safety, regulatory, medical affairs, and other functional areas by providing insights for epidemiologic matters related to vaccine safety, vaccine benefits and risk management and to support safety and regulatory activities, clinical study design and/or safety endpoint qualification/standardization for clinical trials

Minimum Requirements:

  • PhD or equivalent in pharmacoepidemiology, epidemiology or related health science field and substantial experience in the health care environment. Alternatively, an MSc, MD, or MPH with relevant epidemiology experience. 
  • A minimum of 7 years of experience in the pharmaceutical / biotechnology industry with at least 5 years of epidemiology-related experience successfully supporting global clinical development. Experience with vaccine development is highly desired
  • Demonstrated ability to apply advanced vaccine-related epidemiological skills toward successful development and direction of PASS studies, benefit-risk assessments, and/or RWE/RWD projects in the pre- and post-approval environment that can support regulatory decision-making
  • Highly experienced in acquiring/utilizing data from primary and secondary data collection studies; extensive knowledge of existing and accessible large patient databases for use in generating RWE of product-related safety
  • Experience in supporting the preparation of risk management plans, aggregate reports (e.g., PSURS, DSURs)
  • Ability to effectively represent the Epidemiology group on multidisciplinary teams
  • Ability to work effectively with external experts, collaborative groups, and contract research organizations (CROs)
  • Self-starter with good organizational, prioritization, and interpersonal skills who will move forward with key initiatives without being prompted and able to perform multiple tasks as needed for timely support to the vaccine development program from an epidemiology perspective
  • Excellent communication and presentation skills in English (both written and spoken)
  • Ability to travel as needed

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.