Dir/Assoc. Dir, Clinical Analytics

Summary:

The Director/Associate Director, Clinical Analytics position will provide oversight of GCP analytical operations to support Vaxart’s clinical trials.  Responsibilities will encompass oversight of clinical assays conducted to support early-stage Phase 1/2 trials including immunoassay optimization and execution as well as managing data transfer to appropriate databases.  Management of external laboratory testing vendors is required, including overseeing assay qualification and validation for large Phase 2/3 studies. This position will facilitate GCP compliant testing processes, manage a team of clinical analytical associates, ensure the execution of standardized assays and workflows, and review of clinical documents such as protocols, ICFs, SAPs and CSRs. This is a highly visible and dynamic position requiring strong leadership and facilitation skills to balance multiple priorities in a highly matrix/team-based organization.

This position serves as the point person for Clinical Analytical testing and will collaborate with external departments including Research and Clinical for assay development and Quality Assurance to ensure adherence to GCP and company policies, facilitating the implementation and review of QA Policies, SOPs, and Lab Management Systems.  This position will oversee all Clinical Lab Management activities to ensure clinical sample testing, including equipment qualification and maintenance, inventory, as well as shipping and receiving are all supported. The position will coordinate with Research to qualify and assays for GCP purposes. The ability to effectively establish and effectively execute procedures, manage staff, and build risk mitigation strategies into GCP analytical operations is essential.

Responsibilities:

• Manage a GCP Testing laboratory with oversight of clinical sample testing timelines, data transfer and database lock.  
• Manage external laboratory immunoassay testing including assay qualification and validation.
• Support internal GCP operations, oversee instrument installations routine preventive maintenance and validations. Maintain the lab and all documentation in a state of inspection readiness.
• Oversees execution of laboratory experiments and testing both internally and externally with general guidance and Scientific and Technical support from SME.
• Oversee clinical sample management, organize workflows, disbursement, analysis, and archive of test samples.
• Conduct lab investigations, manage invalid results, OOS/OOE studies and deviations, implement CAPA and initiate and review change control documentation and other QC investigations.
• Apply problem solving techniques to ensure the laboratory is regulatory compliant and functions efficiently to meet key milestones and deliverables.
• Communicate the progress of trials results to key stakeholders.
• Effectively collaborate in cross-functional groups including Research, Clinical Operations, and Quality Assurance.
• Review and edit clinical documents such as protocols, investigator brochures, statistical analysis plans and clinical study reports.
• Lead the review of internal SOPs and maintain Veeva Vault library to align with industry standards related to clinical testing and critical reagent life cycle.
• Provide leadership and management support for activities to facilitate training and growth of clinical analysts to ensure competency and efficiency.
• Strong leadership skills with an aim towards fostering a culture of collaboration, high performance, innovation and excellence within the clinical analytics team.
• Advanced knowledge of Safety regulations and FDA guidance.
• Good knowledge and understanding of USP/EP and ICH standards.
• Experience training and managing direct reports.
• Ability to work in the laboratory to optimize high throughput assays. 

Requirements:

• Ph.D.  in Immunology or a related field + 8 years of related experience. 
• A minimum of 5 years’ experience in immunoassay development and/or managing a regulated GCP testing laboratory at an Academic Research Institution or Biotechnology company.
• Background in vaccine immunological clinical testing is highly desired, particularly in managing immune assays in late-stage clinical trials.
• Experience developing and implementing workflows and procedures for clinical testing, sample management, assay performance tracking, and equipment usage.
• Must possess strong written communication skills to ensure SOPs, Clinical documents, and procedures are accurate.
• Experience working with CROs and external testing labs on setting up contracts and data transfer agreements
• Experience with clinical testing in phase 2/3 studies
• Experience implementing and overseeing sample management programs.
• Experience working in Laboratory environment, handling general and specialized equipment.
• Strong critical thinking and decision-making abilities required.
• Strong communication skills, team player, proven negotiation skills.
• Self-driven, independently motivated, data driven and excellent problem-solving ability.
• Self-directed individual who can work with limited direction in a fast-paced, goal-oriented environment.