Director, Clinical Research

  • Full Time
  • Anywhere
  • Posted 2 months ago

Vir Biotechnology

A WORLD WITHOUT INFECTIOUS DISEASE

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.  

RESPONSIBILITIES AND LEARNING OPPORTUNITIES:

  • 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
     

QUALIFICATIONS AND EXPERIENCE:

  • 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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