Director OF Clinical Operations

Vir Biotechnology, Inc. 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 PRO-XTEN 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.Vir Biotechnology has exclusive rights to the universal PRO-XTENmasking platform for oncology and infectious disease. PRO-XTENis a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.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 OPPORTUNITYVir Bio is looking for an 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 DOProvide strategic input and leadership in study set-up and execution of highly complex oncology clinical trials. May support multiple trialsEstablish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriateDevelop and manage study contracts, budgets and timelinesAuthor/review core study documents including protocol and Informed Consent FormsManage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverablesDevelop study plans and relevant study document templates for study teamsAble to support regulatory strategy and assess trial/program impact and RFIs from multiple countriesMay lead RFP process, budget development, and study forecast/planning including timelinesMay perform sponsor oversight site visitsManages 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 metricsReviews monitoring trip reports and track resolution of all action itemsManage team with direct reports within therapeutic areaClinical Operations lead on cross functional project teams and alliance teamsWHO YOU ARE AND WHAT YOU BRINGBachelor of Science degree is required, preferably in the life sciences10+ years of clinical development experience in the biotech/pharmaceutical industryExtensive experience working on oncology clinical studiesExperience in managing and leading clinical studies both in early phase through late stage of developmentExperience in leading all stages of clinical trials including start up, maintenance and closeoutThorough 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 affairsExperience with regulatory compliance audits and inspectionsExperience directing and leading in a complex team environmentAbility to function at a high level when leading a group or managing staff, but ability to manage day-to-day details when neededFlexibility to travel domestically and internationally#LI-AS1#LI-OnsiteWHO WE ARE AND WHAT WE OFFERThe expected salary range for this position is $176,500 to $246,500 per year. 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. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.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