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Salary: USD 176,500 - 246,500 / annual
Vir Biotechnology is seeking an Associate Director of Clinical Operations to lead the execution of complex global clinical trials, with a primary focus on early-phase oncology studies. This is a leadership role based in San Francisco with an expectation of at least 3 days per week in office.
You will independently lead the Study Management Team, oversee clinical vendors and CROs, and be accountable for successful trial execution and conduct. Key responsibilities include vendor selection and management, protocol and study document development, feasibility and study start-up, maintenance, and closure activities.
In this role, you will:
- Provide strategic input and leadership in study setup and execution of highly complex oncology clinical trials, potentially supporting multiple trials simultaneously
- Establish and continuously monitor study timelines and budgets, escalating significant risks or changes as appropriate
- Develop and manage study contracts, budgets, and timelines
- Author and review core study documents including protocols 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
- Support regulatory strategy and assess trial/program impact and regulatory information requests from multiple countries
- Lead RFP processes, budget development, and study forecasting/planning including timelines
- Perform sponsor oversight site visits
- Manage oversight of clinical monitoring activities, including monitoring trip report review and site management to ensure GCP compliance and regulatory adherence
- Track resolution of all action items and site performance metrics
- Manage direct reports within the therapeutic area
- Serve as Clinical Operations lead on cross-functional and alliance project teams
You bring 10+ years of clinical development experience in biotech/pharmaceutical, with extensive oncology clinical study background. You have experience managing and leading clinical studies from early phase through late stage, including all stages from startup through closeout. You possess thorough understanding of FDA, EMEA, ICH, and GCP guidelines, plus cross-functional clinical processes (data management, biostatistics, medical monitoring, drug safety, regulatory affairs). You have experience with regulatory compliance audits and inspections, can direct and lead in complex team environments, and are flexible for domestic and international travel.
