Associate Director, 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-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is 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 OPPORTUNITY Vir 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 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 ...