Director, Clinical Research

  • Full Time
  • Anywhere
  • Posted 2 months ago

Vir Biotechnology


Job Summary:

Vir Biotechnology is seeking a Director of clinical research to support our HBV functional cure program. This position is reporting to the HBV clinical research lead.  


  • Responsible for supporting the scientific aspects of conceptualizing and planning clinical trials and ensuring cross-functional integration, co-ordination and alignment to enable effective and efficient formulation of development plans, study designs, and clinical study protocols
  • Represent clinical research in relevant sub-teams (eg, study management team)
  • Work collaboratively with regulatory and other functions to deliver the clinical research components in the preparation/review of regulatory documents, IND annual reports, IND safety reports, and investigator brochures
  • Provide ongoing medical monitoring for clinical trials including, but not limited to, assessment of eligibility criteria, toxicity management and drug safety surveillance
  • Ensure adherence to regulatory requirements of study conduct and industry standards of ICH/GCP and internal SOPs
  • Serve as part of a team responsible for leading the preparation and/or review of data listings, summary tables, study results, study reports, and clinical sections of regulatory submissions, as applicable
  • Prepare scientific information for presentations to senior management, regulatory agencies, scientific conferences, clinical study investigator meetings, and scientific advisory boards, under the supervision of the HBV clinical lead


  • MD, DO or non-US equivalent of M.D. degree with sub-specialization in Infectious Diseases preferred; PharmD candidates with 5+ years clinical research and drug development experience in infectious diseases and/or liver diseases may be considered
  • Clinical and/or basic research experience with evidence of scientific productivity through grants, authorship, or manuscript
  • Familiarity with infectious diseases and/or clinical Liver Disease medicine is preferred
  •  Basic understanding of ICH/GCP guidelines, FDA and EMEA regulations 
  • Experienced with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
  • Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings
  • Experience and familiarity with pediatric infectious diseases and/or drug development is preferred


Tagged as: hbv hepatitis clinical research

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