Associate Director, Clinical Operations-Oncology (Temporary) at Vir Biotechnology

San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Jun, 26

Salary

119.0

Posted On

24 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Vendor Management, CRO Oversight, Protocol Development, Study Start-up, Study Maintenance, Study Closure, SOP Development, Stakeholder Management, Regulatory Strategy, Budget Management, Timeline Monitoring, GCP Compliance, Clinical Monitoring, Team Leadership, Cross Functional Team Leadership

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 looking for a temporary Associate Director, Clinical Operations, responsible for independently leading global and complex clinical trials. You will lead the Study Management Team, oversee clinical vendors and CRO(s) and is accountable for ensuring the successful execution and conduct of clinical trial(s). In this role, you will be directly managing a large complex early phase oncology study. Activities will include vendor selection and management, protocol and study document development, feasibility/study start-up, maintenance, and closure. You will serve in a leadership role within Clinical Operations and may lead/participate on SOP development working groups and initiatives, manage direct reports, and provide stakeholder management for cross functional teams within clinical development. This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office. WHAT YOU'LL DO Provide strategic input and leadership in study set-up and execution of highly complex oncology clinical trials. May support multiple trials Establish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriate Develop and manage study contracts, budgets and timelines Author/review core study documents including protocol and Informed Consent Forms 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 Able to support regulatory strategy and assess trial/program impact and RFIs from multiple countries May lead RFP process, budget development, and study forecast/planning including timelines May perform sponsor oversight site visits Manages oversight of clinical monitoring activities including monitoring trip report review and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics Reviews monitoring trip reports and track resolution of all action items Manage team with direct reports within therapeutic area Clinical Operations lead on cross functional project teams and alliance teams Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies WHO YOU ARE AND WHAT YOU BRING Bachelor of Science degree is required, preferably in the life sciences 10+ years of clinical development experience in the biotech/pharmaceutical industry Extensive experience working on oncology clinical studies Experience in managing and leading clinical studies both in early phase through late stage of development Experience in leading all stages of clinical trials including start up, maintenance and closeout 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, regulatory affairs Experience with regulatory compliance audits and inspections Experience directing and leading in a complex team environment Ability to function at a high level when leading a group or managing staff, but ability to manage day-to-day details when needed Flexibility to travel domestically and internationally #LI-AS1 #LI-Onsite WHO WE ARE AND WHAT WE OFFER The hourly range for this position is $84 to $119 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. 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

This temporary role involves independently leading global and complex clinical trials, specifically managing a large, complex early-phase oncology study, which includes overseeing study management teams and clinical vendors/CROs. Responsibilities also encompass providing strategic input, monitoring timelines and budgets, authoring core study documents, and managing direct reports within Clinical Operations.