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 SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis.
Vir Bio is seeking a Manager, Clinical Operations, responsible for the execution of Phase 1-3 clinical trials including study set-up and execution, vendor management and sponsor oversight activities. Activities will include vendor selection and management, protocol and study documents development, study start-up, maintenance, and closure. Candidate will lead cross functional study teams and may manage direct reports.
- RFP process, study contract/budget development, and study forecast/planning including timelines
- Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverables
- Develop study plans and relevant study document templates for study teams
- Strategic input and leadership in study set-up and execution
- Manage team with direct reports within therapeutic area
- Lead cross functional study teams
- Main point of contact for operational day-to-day activities
- Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies
- Experience with compound lifecycle from IND to NDA
- Thorough understanding of FDA, EMEA, and ROW ICH and GCP guidelines, as well as thorough understanding of cross-functional clinical processes including and not limited to data management, biostatistics, medical monitoring, drug safety, and regulatory affairs
- Experience with regulatory compliance audits and inspections
- Experience directing and leading in a complex team environment
- Ability to establish priorities, excellent sense of urgency and collaboration with internal/external personnel
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, MS Project and organization tools
EDUCATION AND EXPERIENCE
- Bachelor's or advance degree in a scientific or healthcare discipline preferred, and relevant experiences in industry
- 3+ years of clinical development experience in the biotech/pharmaceutical industry
- Ability to manage multiple priorities in a dynamic work environment
- Experience in managing clinical studies in all phases
- Infectious disease experience preferred
Vir is a company with a compelling mission, "A World Without Infectious Disease". We believe the success of our colleagues drives the success of our business. This is reflected in our ongoing commitment to creating an environment focused on equality, inclusion, and respect. When everyone feels supported and inspired to contribute at their best, we will collectively deliver amazing results.
Vir is committed to attracting and employing a diverse workforce to strengthen our values and mission. Qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disability.
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. We ask that Recruiters not contact or present candidates directly to our hiring manager or employees.