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.
This role will work closely with internal resources and external consultants to help manage our Biospecimen Collection programs for both Clinical and Research Immunology. As a member of both discovery and clinical development project teams he/she will have the opportunity to work in a highly collaborative environment to support projects across all phases of clinical development.
- Clinical Biomarker Program Operations
- Planning, organization and oversight of the entire lifecycle of Biomarker clinical samples through collection, processing, and shipping to analytic partner sites, through final sample disposition.
- Manage external CRO efforts in support of clinical trials, including supporting sample management, data management, and report generation.
- Travel to both national and international clinical sites to conduct Biospecimen feasibility assessments, on-site training on Vir sample processing SOPs, and follow up re-training, as needed.
- Ensure collection, delivery and analysis of biospecimens under the highest standards of quality, ethics, and informed consent at the study level.
- Track clinical biospecimens throughout studies and follow up with sites/study teams and Central Labs/CROs to resolve queries: data entry, reconciliation and monitoring.
- Develop and maintain database(s) to track site training and compliance for maintaining high quality biomarker samples.
- Use multiple technologies to maintain open and frequent communication with internal and external customers, including site study personnel. Maintain a positive working relationship with internal/external customers.
- Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity for sample collection after site launch.
- Represent the department on cross-functional project teams, as requested.
- Work with Immunology Leadership to develop and execute mitigation plans for delayed timelines.
- Research Biomarker Program Operations
- Serve as key point of contact for multiple Research Biospecimen collaborations with academic/community physicians to coordinate biospecimen procurements.
- Oversee and/or perform in-house processing of whole blood biospecimens into PBMC and plasma/serum, according to established Vir SOPs.
- Provide operational input and recommendations into all study related documentation (including protocol, informed consent forms, amendments, and SOP development).
- Manage internal Research Biospecimen database of materials available to Vir Research Teams, and fill requests for sample distributions.
- Attends operations team meetings and investigator meetings, CRO kick-off meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker sample collection and handling procedures.
- Provides responses to biomarker sample related questions or issues from Health Authorities.
- Partners with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, kit contents, shipping conditions and logistics for biomarker samples.
QUALIFICATIONS AND EXPERIENCE
- Master’s degree in immunology, biological sciences or related field with 5+ years’ experience in biotech industry, working in immunology and/or virology related programs.
- 3+ years of experience working in a regulated environment (e.g. GMP, GCP, GTP, Joint Commission, FACT, AABB, etc.).
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples, particularly human PBMC protocols.
- Extensive clinical development experience with evidence of working in teams running clinical studies.
- Project management skills.
- Critical reasoning skills including the identification and resolution of complex problems.
- Detail oriented with the ability to work independently and manage multiple competing priorities.
- Planning, organizational and time management skills.
- Highly flexible in a fast pace global matrix environment.
- Professional interpersonal skills, excellent oral/written communication and influencing skills.
- Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Creates team culture and promotes team spirit.
- Global Vendor Management experience preferred.
- Good knowledge of ICH GCP.
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.