Associate Director, Clinical Operations

Vir Biotechnology•San Francisco, CA

4d•Hybrid

About The Position

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 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.

Requirements

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

Responsibilities

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