San Francisco, CA
Clinical Development -
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of five product candidates targeting hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis.
Vir Biotechnology (Vir), a San Francisco based company focused on infectious disease, seeks a Clinical Scientist on the Respiratory Program that will support clinical study design and conduct ranging from Phase 1-4 studies as well as the management of clinical development plans for new and ongoing assets. Reporting to the Director, Clinical Research in the Respiratory Program, this Clinical Scientist is a crucial position at Vir. You will play a key role liaising with clinical pharmacology and regulatory functions to develop high quality clinical documents for study use and regulatory submission and with clinical operations to ensure successful execution of clinical studies.
Act as an associate clinical monitor under the supervision of the Medical Director/Medical Monitor for assigned product development programs, including support for design and conduct of clinical trials (i.e. protocol and SAP development, ongoing data review, response to IRB/MoH queries)Provide direction and liaise with clinical operations to ensure successful execution of clinical studies Act as clinical representative on study teams, development teams and at interdepartmental meetings to discuss progression and execution of clinical programsDevelop, draft and/or review clinical study reports and help to manage the presentation of key clinical findings to internal and external stakeholdersSupport critical interpretation of results of completed clinical trials for important Go/No-go decisions and in preparation for submission to relevant regulatory authoritiesDraft and develop documents for assigned development programs (i.e. briefing books for advisory boards or regulatory meetings, clinical development plans)Contribute to annual updating of product Investigator BrochuresResearch published literature and regulatory documents related to clinical development plans, protocol development and execution and other scientific activities of the departmentAssessment of literature and disease background for in-licensing opportunitiesSupport creation of in-house medical training and investigator meeting materialsConduct trainings for internal and/or external study personnel to support ongoing studies (IB, protocol, therapeutic area, etc.) Support advisory board meetings including development of meeting materials, and in general, working with external advisors as needed to support ongoing programsAssist with conceptualization, review and authoring of abstracts, posters and manuscripts to support the product publication plan, and lead effort as appropriateContribute to the scientific, clinical, and commercial development of product candidates (both internal and external), including medical and scientific input for due-diligence processes and presentation of key findingsOccasional travel will be required.
QUALIFICATIONS AND EXPERIENCE
3+ years of relevant research or work experience Industry experience with study design, conduct and finalization of study reports strong plusBasic knowledge of clinical trial design, biostatistics, clinical pharmacology, pharmacokinetics; familiarity with infectious diseases a plusCan independently conduct review of literature and present in depth scientific analysis of published literatureAbility to author abstracts and contribute to scientific publications. Able to hold a dialogue regarding the most current scientific and/or medical thinking.Has the ability to adopt new techniques within the discipline. With supervision, has the ability to plan and carry out clinical trials. Ability to independently solve routine problems within discipline. Exercises independent judgment to determine and recommend appropriate actions within the discipline. Recognizes appropriate opportunities to apply skills and share clinical insight across the organization.Ability to travel domestically and internationallyStrong written and verbal communication skills, able to articulate complex concepts to internal and external team members and contribute to authoring reports, SOPs, regulatory filings, or other relevant documentsAbility to work in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
VIR is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
The Human Resources team manages the recruitment and employment process for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.