Judith Neville

• Supported global vaccine programs and therapeutic vaccine trials across covid-19, RSV, influenza, Marburg, Sudan, HIV, and HBV, managing trial budgets upto $800M USD.
• Worked across clinical, regulatory, safety, and manufacturing teams to keep programs aligned with milestone timelines and required deliverables.
• Helped maintain portfolio governance and risk controls to protect timelines and budget adherence across high-value programs.
• Led task force to automate protocol deviation detection and tracking, generating about $500K in annual savings and improving compliance visibility.
• Served as division subject matter expert for therapeutic vaccines, developed training, wrote white papers, and presented scientific and operational guidance at international forums, including WVC and xTalks.
• Built strategic partnerships with sponsors, investigators, and KOLs to strengthen program execution and speed up decision-making.
• Mentored multidisciplinary global teams and set performance expectations that supported operational excellence.

• Acted as senior client liaison, translating product strategy into actionable operational plans and fostering long-term client partnerships.
• Directed portfolio-level delivery of complex global clinical programs, ensuring studies met scope, budget, and regulatory quality standards.
• Led and coached project management leaders, strengthening delivery capability and aligning operational execution with sponsor strategy.
• Managed integrated project and risk management frameworks, ensuring milestone achievement and regulatory readiness for submissions.
• Partnered with PMO and functional heads to implement process improvements and performance metrics that enhanced operational efficiency across portfolios.
• Developed program quality standards and CAPA processes, ensuring compliance and enhancing stakeholder confidence.
• Represented operations in governance forums, delivering data-driven insights to support executive decision-making.

• Led cross-functional teams (investigators, statisticians, clinicians, operations) to refine study design, regulatory strategy, and implementation plans for pilot and large-scale trials.
• Oversaw research service delivery, managing grant facilitation, budget development, project management, and operational feasibility to maintain scientific rigor and compliance.
• Acted as principal liaison for investigators to translate research concepts into scoped clinical protocols aligned with national priorities and funding requirements.
• Promoted institutional research services to external partners, enhancing engagement in grant-funded HIV vaccine and therapeutic studies and elevating institutional visibility.
• Negotiated service agreements and study contracts with legal and research administration teams to secure favorable terms and clear deliverables.
• Designed and delivered training for study coordinators and site staff on protocol conduct, safety reporting, and GCP, improving site readiness and data quality.
• Authored institutional submissions supporting the CIHR HIV Clinical Trial Network five-year renewal and led strategic initiatives, including business case development for a hospital-based clinical research facility.

• Co-developed the Integrated Product Development Plan and Target Product Profile for AQX-1125, aligning clinical and regulatory strategy with partnership objectives.
• Led design, initiation, and operational management of early-phase clinical trials in the UK, including CRO oversight, vendor selection, and day-to-day execution.
• Implemented clinical operations SOPs to enhance organizational readiness and streamline cross-functional coordination with vendors.
• Authored regulatory and scientific documentation, including sections of the Investigators Brochure and presentations, to facilitate submissions and enhance stakeholder communication.
• Prepared clinical summaries and due-diligence materials to aid business development and partnership activities with investors and collaborators.

• Led early clinical development proof-of-concept trials for XEN402 (oral and topical formulations), advancing the program from first-in-human through Phase II while ensuring safety and data integrity.
• Managed CRO partnerships and vendor performance to ensure high-quality execution within timelines, budget, and compliance standards.
• Prepared and managed IND and Health Canada submissions, authoring critical clinical sections of regulatory documents to support timely approvals and compliance.
• Designed protocols and interpreted clinical data to align endpoints and safety assessments with regulatory and commercial objectives, facilitating informed decision-making.
• Maintained project plans, budgets, contracts, and accrual forecasts, delivering regular progress and financial updates to senior management to ensure project alignment with strategic goals.

• Authored strategic plan for Immunization Group at Centre for Disease Control, identifying priority areas for funding and program development to enhance immunization initiatives.
• Developed benchmarking metrics and analyzed access to public health systems, informing funding prioritization and resource allocation to optimize program effectiveness.
• Acted as liaison for Provincial Health Authorities and Federal First Nations Health representatives, facilitating stakeholder engagement and coordination.
• S synthesized data and stakeholder feedback to support program planning and guide implementation decisions, ensuring alignment with community needs.

• Led a high-risk first-in-human monoclonal antibody trial as Project Team Lead, overseeing study design, operational strategy, and risk mitigation for patient safety and regulatory compliance.
• Oversaw regulatory and clinical document review, outsourcing strategy, vendor selection, and project training, ensuring GCP compliance and readiness for inspections.
• Aligned the clinical development plan and target product profile with cross-functional leaders to define clinical and regulatory milestones that guide long-term development.
• Coordinated communication between PI, DSMB, and KOL steering committees to support informed decision-making and maintain project alignment.
• Served as Operations Representative on Product Development Team for Inflammation and Autoimmunity, facilitating strategic planning and advancing early-stage biologic development.

The Extent of Genotype-specific Humoral Immunity Produced on Infection with Hepatitis C Virus: Relevance for Serological Screening and Diagnosis

Specialization in immune response and monoclonal antibodies