Seth Toback

About Seth Toback

Board-certified physician-scientist with over 20 years’ experience leading innovative biotech and pharmaceutical development in vaccines, respiratory, and infectious diseases. Proven track record in advancing pipelines from research to regulatory approval, including managing phase I-IV clinical trials and real-world evidence studies. Expertise in regulatory strategy, biomarker discovery, and platform technologies such as recombinant proteins and monoclonal antibodies. Skilled in building and leading high-performing teams and forging strategic collaborations to accelerate product development and commercialization. Passionate about translating scientific advances into impactful therapies for respiratory and infectious disease patients.Areas of expertise: Respiratory viruses, vaccines, diagnostics/biomarkers, asthma, allergy/anaphylaxis.

Experience

1. Senior Vice President, Global Medical Affairs

   Novavax

   Jan 2022 — Present · Raleigh, NC, US

   Founded and scaled a high-performing Medical Affairs department, establishing a strategic infrastructure to support biopharmaceutical vaccine development, regulatory compliance, and commercialization, growing the team to over 45 FTEs.•Led global teams including Scientific Communications, Medical Information, Phase 4/Post-Marketing Surveillance, Real-World Evidence (RWE), and Medical Science Liaisons to drive scientific exchange, data dissemination, and stakeholder engagement.•Developed and executed integrated medical strategies aligned with product lifecycle management, disease education, and market access, reinforcing the company’s position in infectious disease and vaccine markets.•Oversaw clinical and real-world evidence generation activities, including observational studies and post-approval safety monitoring, to support regulatory submissions, label expansions, and payor strategies.•Managed all facets of COVID-19 vaccine medical activities, including clinical data interpretation, adverse event reporting, and the development of scientific communication plans for healthcare professionals and regulators.•Collaborated with regulatory and commercial teams to ensure alignment of medical plans, supporting rapid vaccine approval, market launch, and ongoing post-marketing success within global health authorities.•Implemented strategic initiatives for disease awareness campaigns, scientific education, and KOL engagement, enhancing the medical and scientific credibility of the vaccine portfolio.

Education

• Children's Hospital of Pittsburgh

  Board Certification, Residency in Pediatrics

• Tufts University School of Medicine

  Doctor of Medicine (MD)

• Carnegie Mellon University

  Master of Medical Management, Business Administration and Management, General

• McGill University

  BS, Physiology

Skills

• Protocol
• Medical Education
• Vaccines
• Public Speaking
• Clinical Research
• Pediatrics
• Respiratory Disease
• Immunology
• Medical Affairs
• Drug Development
• Promotional Review
• Internal Medicine
• Infectious Diseases
• Biotechnology
• Working with Physicians
• Publication Development
• Managed Care
• Clinical Development
• Therapeutic Areas
• Postmarketing Safety Studies
• Phase 4 Studies
• Advisory Boards
• Viruses
• Kol Development
• Pulmonology
• Clinical Trials
• Medical Writing
• Physicians
• Neurology