Vir is a clinical-stage immunology company with a compelling mission; "A World Without Infectious Disease". We are focused on combining immunologic insights with innovative technologies. We have assembled four technology platforms that are designed to stimulate and improve the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of product individuals targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Vir Bio is seeking a Senior 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.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Is responsible for the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations.
- Leads implementation of clinical protocols, data collection systems and clinical study reports.
- Support new and ongoing clinical trials and leads cross functional study teams.
- Lead clinical and regulatory files
- Provides oversight and management of investigational sites, clinical consultants, Contract Research Organizations and other vendors.
- Selects, develops and evaluates personnel and vendors to ensure the efficient operation of the function.
- Manages direct report(s) and development of junior team members
QUALIFICATIONS AND EXPERIENCE
- BS/MS and 6+ years of clinical development experience in the biotech/pharmaceutical industry
- Experience in managing clinical studies in all phases
- 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
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment 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 external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.