Senior Director, Clinical Research – Infectious Disease

Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including RSV/MPV and HPV.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™.

Vir Biotechnology seeks a Senior Director of Clinical Research, Infectious Disease. Reporting to the VP for Clinical Development, the Senior Director of Clinical Research, Infectious Disease, is a crucial position at Vir with the primary responsibility of leading the HDV Clinical Development Subteam. You will play a key role at all stages of development, focusing initially on late stage development of the HDV portfolio with opportunities for opportunities across the Vir portfolio from across the drug discovery stage through product registrations world-wide. 

This role is open to remote employees. Vir only supports remote employees within the United States and reserves the right to approve work locations.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES:

• Lead the HDV Clinical Development Subteam and serve as the clinical representative on the Program Team.
• Work with the clinical team on all scientific aspects of conceptualizing and planning trials.
• Oversight for ongoing and planned clinical trials including publication planning, investigator meetings and Scientific Advisory Boards.
• May serve as a resource to other functions in evaluating business development opportunities.
• Work with a senior member of the clinical development team to provide high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.
• Collaborate with the clinical development team to provide ongoing clinical monitoring for clinical trials including, but not limited to, assessment of eligibility criteria, toxicity management and drug safety surveillance.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Vir Bio SOPs.
• Collaborate with the clinical development to the clinical research components in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
• Coordinate the collection and assimilation of ongoing data for internal analysis and review.
• Manage the preparation and/or review of data listings, summary tables, study results and scientific presentations.
• Help prepare scientific information for presentation at scientific conferences and clinical study investigator meetings.
• Analyze and summarize data for presentation to senior management and regulatory agencies.
• Provide assistance and support in managing relationships with regulatory affairs, biostatistics, and other non-clinical departments. Provide strategic guidance on non-regulatory clinical trial plans.
• Cultivate relationships with therapeutic area opinion leaders worldwide.
• Potential to build a team.

QUALIFICATIONS AND EXPERIENCE:

• 13+ years of relevant experience in industry and preferably with ID specialization or relevant work.
• You will have the experience developed by a strong track record in the field of clinical research. BLA or NDA experience will be highly.
• Familiarity with good clinical practices and International Conference on Harmonization Guidelines.
• Comfortable discussing the science and research approaches important for study protocol design, clinical endpoints and data interpretation.
• Leadership experience setting a vision, leading change, and mentoring others.
• Experience formulating clinical strategies.
• Skillset to drive consensus among individuals from a variety of cultures and disciplines.

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The expected salary range for this position is $225,500.00 to $329,500.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Vir’s compensation and benefits are aligned with the current market and commensurate with the person’s