Sr. Director, Real World Evidence
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Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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.
Summary of the Position:
We are seeking a highly motivated and experienced individual as Global Senior Director within the Real-World Evidence (RWE) function of the Medical Affairs organization. The RWE Senior Director is essential in leading the Global and specific Regions by planning and delivering health economic/outcomes research that is scientifically credible and demonstrates high-quality evidence aligned with the needs of key decision makers responsible for fostering global healthcare policies and standards of care. The RWE Senior Director will lead or support multiple assets at various phases of development and will be accountable for the development of evidence generation plans.
This position is remote-based. International travel is anticipated.
Responsibilities include but are not limited to:
- Lead the overall Asia-Pacific and America Region evidence generation for Novavax vaccines as it relates to RWE studies, health economic modeling, value communication, observational research pragmatic RWE trials, and field tool development.
- Serve as Scientific Lead for large observational / RWE studies and to ensure RWE studies meet the required level of scientific credibility. Includes serving as the scientific expert for all Novavax vaccines and support the development and execution of post-authorization studies including post-authorization effectiveness studies.
- Understand and proactively anticipate the RWE (Asia-Pacific & Americas) needs for vaccine development, regulatory and market access, and make recommendations on fit-for-purpose data and analytics solutions across different countries.
- Stay current with and support adoption within Novavax of analytical methodologies, tools and applications to ensure fit-for-purpose and innovative approaches; identify new research ideas and data sources for RWE that promote an innovative mindset throughout the organization.
- Work closely with cross-functional colleagues in Asia-Pacific & the Americas (e.g., Medical, Commercial, Market Access, Policy) and globally (e.g., RWE, Global Vaccine Safety, Epidemiology, Clinical Development/Operations, Regulatory Affairs) to ensure the RWE (Asia-Pacific & Americas) strategy optimally addresses current and future needs.
- Ensure quality, visibility, and continuity of health outcomes activity conducted.
- Develop RWE plans, design innovative RWE studies, implement robust analyses, and collaborate with multiple cross-functional stakeholders and partners throughout the organization to demonstrate the value of Novavax vaccines.
- Accountable of taking the health economic/outcomes research plan from concept to publication. This position will oversee, contribute to, and manage study quality, scientific content, resources, project plan, budgets, and vendors.
- Define appropriate research questions and data sources, study design, and analytical approaches that are rigorous and fit-for-purpose.
- Generate evidence to assist payers, healthcare provider decision makers, policy makers, and patients in understanding the value of our vaccines.
- Attend and actively participate as an RWE vaccine expert to key internal and external stakeholders. In addition, can participate in key meetings as the industry expert on key external public health panels and working groups.
- Maintain a high level of knowledge regarding the scientific, clinical, public health, and commercial developments in multiple disease areas, as well as a robust understanding of country-specific evidence needs by key population-based decision makers.
- Advanced degree (e.g., PhD, PharmD, DrPH, MD, or equivalent) in an RWE-related field (e.g., epidemiology, outcomes research, health services research, health economics, health policy). A clinical background should be supplemented with advanced quantitative training demonstrated by a minimum of a Master’s degree in a related field or equivalent experience.
- Ten years of relevant leadership and research experience (e.g., academia, consulting, and/or industry); a minimum of six years in the pharmaceutical/biotechnology/ vaccine industry, including at least 4 years of experience being accountable for RWE across multiple countries.
- In-depth expert knowledge of RWE and its application to demonstrate vaccine safety and effectiveness.
- Experience starting and executing post-licensure studies including protocol design, budget management, as well as assignment and oversight of CROs and other vendors.
- Demonstrated track record of leading and executing multiple research projects with no or minimal supervision using real-world data from claims, electronic health records, registries, biobanks, and/or digital applications.
- Demonstrated success with implementing post-market studies and a strong understanding of study initiation and management at the operational level.
- Comprehensive understanding of the pharmaceutical industry and regulatory environment concerning post-licensure commitments.
- Demonstrated ability to build credible professional relations with key opinion leaders/external experts to enhance study enrollment and publication plans.
- Well-developed conceptual and integrative thinking with capability to access internal and external resources for advice.
- Demonstrated proficiency in more than one research methodology (claims analysis, cost effectiveness, budget impact modeling, meta-analysis).
- Demonstrated ability to publish study results in peer-reviewed journals and present those results at scientific conferences.
- Ability to travel up to 30%, including international travel.
- Experience with Registry enrollment and evidence generation using Registry data.
- Experience with vaccines preferred, specifically in conducting post-licensure health economic/outcomes research studies.
- Experience with leading multiple studies in various countries/global regions.
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.
Gaithersburg, Maryland, USA
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