Jobs at Vir Biotechnology

Lead nonclinical toxicology strategy across infectious disease and oncology programs. Oversee GLP/non-GLP safety studies, design and interpret toxicology reports, support regulatory submissions (IND/BLA/CTAs/IMPDs), advise cross-functional teams, and drive safety risk assessment and lifecycle management.

The Senior Manager, Quality Control oversees QC strategy execution, ensuring timely delivery of testing activities and regulatory compliance across programs and testing partners.

Lead development, validation, and implementation of bioanalytical methods (PK, PD, ADA) for biologics; manage and mentor a bioanalytical team; oversee method transfers and CRO partnerships; support regulatory filings, audits, and cross-functional project planning to meet study objectives and compliance requirements.

Lead drafting, review and negotiation of clinical trial/site and vendor agreements for global multi-site studies. Manage end-to-end CTA processes and strategy, update templates and playbooks for country compliance, partner with Clinical Operations and Legal on risk and delivery, and co-manage external site contract/vendor service providers and governance.

The Senior Director will lead clinical research in oncology, overseeing development strategies, study execution, and regulatory interactions while mentoring clinical scientists.

Lead project management for partnered and internal research programs across discovery to early clinical development. Create integrated plans, track milestones and risks, facilitate cross-functional meetings, support governance and portfolio reviews, coordinate transitions to development, and drive research operations and strategic initiatives to improve governance, resource planning, and operational excellence.

Serve as a strategic, hands-on HR Business Partner for assigned client groups, advising leaders on workforce planning, organizational design, talent management, change management, performance, and employee experience. Coach managers, partner with HR centers of excellence, use people data to inform decisions, support HR program implementation, and enable organizational scaling and leader capability in an oncology-focused biotech environment.

Lead global, complex oncology clinical trials including vendor/CRO management, protocol and study document development, feasibility/start-up, maintenance and closeout. Manage study timelines, budgets, monitoring oversight, team members, and cross-functional stakeholder engagement while ensuring regulatory and GCP compliance.

Lead competitive intelligence for early-stage oncology programs by gathering and synthesizing external scientific and commercial insights (including LLM/agentic AI), maintaining competitor profiles, briefing senior leadership and cross-functional teams, and covering major conferences to inform clinical, program, and corporate decisions.

Lead biostatistics, statistical programming, and clinical data management across phases I-III; develop and execute clinical biometrics strategy, drive regulatory submissions, mentor teams, implement RWD analytics, and manage budget/resource allocation.

The Senior Director leads Clinical Pharmacology and Translational PK/PD operations, overseeing drug development processes for infectious diseases and oncology, managing teams, collaborating with cross-functional teams, and ensuring regulatory compliance.

Lead CMC regulatory strategy for assigned products across clinical development and commercialization. Prepare and review CMC components for INDs/CTAs and BLAs/MAAs, manage regulatory risks and HA interactions, support change control and inspection readiness, ensure dossier compliance with global requirements, and drive continuous improvement in regulatory processes while collaborating with Technical Operations and Regulatory Affairs.

Lead and produce high-quality regulatory submission documents (protocols, IBs, CSRs, Module 2/5 summaries, labeling, briefing packages) for FDA/EMA. Ensure compliance with ICH/GxP, manage writing projects and timelines, collaborate with cross-functional teams, and define SOPs and best practices.

Create, edit, and ensure compliance of regulatory submission documents (protocols, IBs, CSRs, Module 2/5 summaries) for global health authorities. Translate complex clinical data into clear text, coordinate cross-functional inputs, manage writing timelines, and advise teams on regulatory writing best practices to support IND/NDA/MAA and other submission activities.

Perform regulatory writing and editorial/QC for submission documents (protocols, IBs, CSRs, briefing packages, NDA/IND/MAA components). Verify accuracy and consistency versus source data, apply style guides and templates, proofread and copyedit, prepare eCTD/CTD submission materials, communicate QC findings, manage document workflows and timelines, and improve QC tools and SOPs.

Lead clinical pharmacology and pharmacometrics strategy across drug development stages. Design and execute PK/PD, PopPK, and exposure-response modeling; support study design, dataset preparation, regulatory documents, and cross-functional teams to inform dose selection from FIH through market authorization.