Senior Director, Clinical Operations Oncology

Vir Biotechnology•San Francisco, CA

1d•Hybrid

About The Position

Vir Biotechnology is seeking an experienced Senior Director of Clinical Operations to provide portfolio-level strategic and operational leadership for multiple complex global oncology programs. The role translates clinical development strategy into executable operational plans and is accountable for delivering studies against timelines, budgets, quality standards, and decision-critical milestones while identifying and resolving risks affecting program objectives. It is a hands-on leadership position spanning study execution, program governance, alliance management, operational excellence, and oncology portfolio growth. The Senior Director establishes operational strategy for assigned programs and provides sponsor oversight of CROs, clinical sites, laboratories, and specialty vendors. As a member of cross-functional program and study teams, the role provides operational leadership from protocol concept and country and site strategy through database lock, study closeout, and regulatory submission support. The position also leads initiatives in portfolio governance, resource planning, process improvement, SOP development, inspection readiness, and scalable operating capabilities. The position is based at Vir Biotechnology’s San Francisco headquarters, with an expectation of working in the office at least three days per week. Domestic and international travel may be required as needed.

Requirements

Bachelor’s degree in life sciences or a related field.
15+ years of clinical development experience in the biotechnology or pharmaceutical industry.
Significant experience overseeing complex global oncology clinical trials, with deep expertise in early-phase oncology development.
Experience leading first-in-human and early-development oncology trials, including dose-escalation, backfill, expansion, signal-seeking, and dose-optimization studies.
Strong understanding of clinical trial design and execution, including operational considerations in oncology studies.
Demonstrated expertise in global study start-up, country and site feasibility, investigator engagement, enrollment forecasting and optimization, and recruitment planning across academic and community oncology networks.
Experience developing recruitment strategies for biomarker-selected populations, competing trials, screen failure, and complex referral pathways.
Extensive knowledge of FDA, EMA, ICH GCP, and other global regulatory requirements.
Experience managing CROs and vendors across global clinical development programs.
Experience supporting regulatory inspections, audits, and inspection-readiness activities.
Ability to balance strategic leadership with hands-on execution, make timely decisions with incomplete or evolving data, and resolve complex operational issues in a fast-paced, resource-conscious biotechnology environment.
Ability to influence cross-functional program strategy and drive timely decisions in a fast-paced biotechnology environment.
Experience contributing to departmental initiatives, process improvements, and operational excellence programs.
Ability to travel domestically and internationally as needed.

Nice To Haves

Experience supporting development of novel oncology modalities such as T-cell engagers, bispecific antibodies, immuno-oncology therapies, cell therapies, cytokine-based therapies, or related platforms.

Responsibilities

Oversee implementation of clinical development plans for multiple global oncology trials, delivering against timelines, budgets, quality standards, and milestones.
Lead operational execution of first-in-human, dose-escalation, dose-optimization, backfill, combination, and expansion-cohort oncology studies, including cohort activation, safety oversight, pharmacokinetic and biomarker sampling, and timely data delivery.
Partner with Clinical Development, Translational Medicine, Clinical Pharmacology, Medical Monitoring, Biometrics, Regulatory Affairs, Safety, Clinical Supply, and other functions to align operational and clinical objectives.
Translate program strategy into integrated operational plans covering country and site strategy, start-up and enrollment assumptions, patient and site engagement, CRO and vendor selection, resourcing, budgets, clinical supply interfaces, data-delivery milestones, and risk mitigation.
Provide sponsor oversight of CROs and ancillary vendors through governance, performance metrics, escalation, quality and risk review, financial oversight, and corrective and preventive action accountability.
Implement and oversee risk-based quality management, sponsor-oversight activities, and inspection-readiness strategies across assigned studies.
Serve as the Clinical Operations subject matter expert for assigned studies and lead initiatives involving KPI tracking, process improvement, and adherence to protocols, project plans, and GCP requirements.
Partner with senior leadership to foster an environment that attracts and retains high-performing Clinical Operations professionals.
Build, lead, and develop a high-performing Clinical Operations team, including managing, coaching, and developing direct reports.
Mentor junior Clinical Operations colleagues and help build capabilities for a growing oncology portfolio.
Develop company SOPs, guidelines, and efficient systems with the Clinical Operations team to improve departmental effectiveness and ensure compliance with FDA regulations and current ICH GCP guidelines.
Represent Clinical Operations on program, study, governance, and portfolio-planning teams; provide operational recommendations, scenario analyses, and risk assessments, and escalate decisions needed to protect program timelines and objectives.
Serve as the operational lead for alliance and co-development programs, represent Clinical Operations in joint governance forums, and facilitate cross-company operational alignment.
Lead Clinical Operations planning for emerging oncology assets moving from preclinical development into the clinic, including first-in-human strategy, country and site assessment, vendor and systems readiness, initial budget and resource assumptions, and execution planning aligned with regulatory submission and study-start milestones.