(Senior) Director, Safety Epidemiology and Benefit Risk
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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.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
The (Senior) Director, Safety Epidemiology and Benefit Risk, Global Vaccine Safety is responsible for developing, managing, executing, and providing recommendations for epidemiologic activities in close collaboration with cross-functional teams across the Novavax organization.
Responsibilities include but are not limited to:
- Overall responsibility for the planning, design, conduct, and analysis of regulatory-grade epidemiologic post-marketing safety studies.
- Conduct observed versus expected analyses using internal safety data (eg, global spontaneous reporting databases) as well as develop epidemiological insight for the reporting and outcomes from external databases or agencies.
- Conduct extensive epidemiology and benefit risk analysis.
- Identification of relevant patient-level 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.
- Present epidemiologic research plans and results internally, to external agencies, and health authorities such as FDA, EMA, CDC, and WHO; and at scientific conferences.
- Maintain close working relationships with Novavax development teams in the areas of Global Vaccine Safety, clinical, regulatory, medical affairs, and other functional areas by providing insights for epidemiologic matters related to vaccine safety studies, vaccine benefits and risk management, and other needs as needed.
- PhD or equivalent in pharmacoepidemiology, epidemiology or related health science field.
- A minimum of 7 years of experience in the pharmaceutical 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 safety study 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 (e.g., Real World Data) for use 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.
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.
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)
Gaithersburg, Maryland, USA
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