Director/associate Director, Clinical Analytics

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and dsRNA agonists.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for a Director/ Associate Director, Clinical Analytics to join our growing South San Francisco team!

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 related experience.
• 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 with implementing and overseeing sample management programs.
• Experience working in Laboratory environments, 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.

In accordance with California’s Pay Transparency law, Vaxart’s base salary range for this position is approximately $170,000 - $260,000 USD annually. The actual salary for this role will vary based on a variety of factors including education, job-related knowledge, and experience. This range does not include equity, benefits, bonuses, or other non-monetary compensation which may be included.

Vaxart offers team members a competitive compensation and benefits package, including a robust health plan, bonus program, stock options, 401(k) with employer matching, tuition assistance, and work-life balance.

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by.

NOTICE TO RECRUITERS AND STAFFING AGENCIES: Vaxart, Inc. has an internal recruiting department. Vaxart may supplement that internal capability from time to time with assistance from temporary staffing agencies, placement services, and professional recruiters ('Agency'). Agencies are hereby specifically directed NOT to contact Vaxart employees directly to present candidates. Vaxart’s recruiting team or other authorized Vaxart personnel must present ALL candidates to hiring managers.

To protect the interests of all parties, Vaxart will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to Vaxart, including unsolicited resumes sent to a Vaxart mailing address, fax machine or email address, directly to Vaxart employees, or to Vaxart's resume database will be considered Vaxart property. Vaxart will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Vaxart will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.

The Agency must obtain advance written approval from Vaxart's recruiting function to submit resumes, and then only in conjunction with a valid fully executed contract for service and in response to a specific job opening. Vaxart will not pay a fee to any Agency that does not have such an agreement in place.

Agency agreements will only be valid if in writing and signed by an officer of Vaxart or their designee. No other Vaxart employee is authorized to bind Vaxart to any agreement regarding the placement of candidates by Agencies. Vaxart hereby specifically rejects, and denies any liability under, any agreement purporting to be accepted based on negative consent, negotiation with a candidate, performance, or any means other than the signature of a Vaxart officer.