Manager, Clinical Operations (Temporary) at Vir Biotechnology

San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Feb, 26

Salary

85.0

Posted On

15 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Vendor Management, CRO Management, Study Execution, Stakeholder Management, Regulatory Compliance, Team Leadership, Project Management, eTMF Management, Data Management, Biostatistics, Medical Monitoring, Drug Safety, Regulatory Affairs, Inspection Readiness, Cross-Functional Collaboration

Industry

Biotechnology Research

Description

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best. THE OPPORTUNITY Vir Biotechnology is seeking a Manager, Clinical Operations (Temporary), responsible for leading and supporting multiple Phase 1-3 clinical trials including study execution, vendor management and sponsor oversight activities. Activities will include vendor and CRO oversight, eTMF management, trail maintenance, and closure. This Position is located in our San Francisco headquarters with an expectation of 3 days per week in office. WHAT YOU'LL DO Provide strategic input and leadership in study execution of clinical trials Support ongoing clinical trials and may lead cross functional study teams Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverables Support the internal study management teams by developing agendas, drafting meeting minutes, organizing meetings Develop study plans and relevant study documentation May serve as the main point of contact for day-to-day operational activities; lead cross-functional team meetings Act as cross functional resource/SME on ICH/GCP issues; facilitate inspection ready status of clinical trials Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies Oversee TMF to ensure clinical trial documents are filed according to the TMF management plan Support department level initiatives and deliverables WHO YOU ARE AND WHAT YOU BRING Preferred Bachelor’s degree with 6+ years of industry experience Experience in managing late stage (Phase 2/3) clinical trials; study closeout experience preferred Experience in CRO and vendor management Experience in leading cross-functional team meetings Able to successfully work across multiple active clinical trials at once Experience with compound lifecycle from IND to NDA Thorough understanding of FDA, EMEA, and ICH and GCP guidelines, as well as thorough understanding of cross-functional clinical processes, including but 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 Previous experience as a CTM preferred #LI-AS1 #LI-Hybride WHO WE ARE AND WHAT WE OFFER The expected hourly range for this position is $64 to $85. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics. This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment. Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us 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. For hires based in the United States, Vir Biotechnology, participates in E-Verify. Candidate Privacy Notice

Responsibilities

Lead and support multiple Phase 1-3 clinical trials, including study execution and vendor management. Oversee TMF management and ensure clinical trial documents are filed according to the TMF management plan.