Job Description

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 Medical Director/Medical Monitor to join our growing South San Francisco team!

The Medical Director/Medical Monitor (MD/MM) collaborates with members of the clinical operations team to provide medical input and safety oversight of all Vaxart clinical trials. The MD is also responsible for Sponsor contact and engagement with CRO MMs and clinical site investigators and participates in the development and review of clinical trials and supports clinical plans and documents.

Responsibilities:

• Provides broadly based regulatory, ethical, GCP and medical evaluation of key documents including protocols, informed consent documents, and investigator brochures for proposed and ongoing clinical trials, as well as related administrative activities to help ensure efficient, effective, and compliant study conduct and safety oversight of Vaxart vaccines clinical trials.
• Works closely with study teams to facilitate timely, complete, accurate, and informative adverse event reporting to other regulatory and oversight entities such as FDA and IRB's.
• Performs investigational product safety reviews and participates in the preparation of technical and regulatory documents.
• ·Acts as the Sponsor Medical Monitor of record and provides medical safety monitoring for ongoing clinical trials conducted under FDA INDs and ex-US Competent Authorities.
• Reviews and interprets clinical data on a real-time basis, including report review, teleconferences, and other activities in collaboration with the scientific research, biostats and Data Management groups, if applicable, and makes recommendations and determinations as appropriate and required to help ensure the protection of study participants.
• Reviews serious adverse event reports from clinical sites to determine if an Investigational New Drug (IND) Safety Report is needed.
• In conjunction with responsible investigator, oversees and approves the preparation of safety information for reporting to regulatory bodies.
• Ensures, in conjunction with Regulatory Affairs, compliance with regulatory reporting requirements for safety reporting in domestic and international clinical trials.
• Assists with preparation of INDs and IND Annual Reports as they relate to clinical safety information.
• Provides expert consultation, as appropriate, to Investigators and study teams on protocol procedures. related to safety and compliance with regulations and guidance, including, but not limited to, population selection criteria and screening, safety testing, pausing and halting, blinding, SMC, DSMB and other safety oversight, communication of information and risks in plain language for informed consent, toxicity table selection, and rules governing protocol evaluation and reporting of serious adverse events, unanticipated problems, lab abnormalities, subject withdrawals, in accordance with regulatory requirements.
• Serves on assigned project/product teams or sub teams to provide guidance regarding safety-related issues.

Requirements:

• Medical Doctoral degree (e.g., M.D. or D.O.) from an accredited medical college or university, in a field related to biomedical research or life science.
• Must have a minimum of 5-years' experience as a PI or MM for clinical research (vaccines a plus).
• Must have a valid US Medical License and board certification in a relevant specialty or subspeciality.
• Knowledge of, or experience with, vaccine safety within the pharmaceutical industry, academic facility, or clinical research involving vaccines, infectious diseases, or relevant field.
• Knowledge of pharmacovigilance, clinical safety regulations and guidelines, and clinical research trials methodology, design, implementation and analysis.
• Knowledge of US FDA regulations, ICH/GCP guidelines, the NIH's Office of Human Research Protections regulations, and clinical trials research and management.
• Ability to communicate effectively with the internal and CRO/vendor clinical study staff.
• Ability to render decisions and policy interpretations and provide guidance and leadership in the performance of complex planning, coordination, and evaluation of duties for a clinical trial project.
• Ability to independently identify problems and effectively offer solutions.
• Ability to comprehend, integrate, and interpret scientific and medical data from a variety of sources.
• Ability to develop and edit scientific manuscripts for peer-reviewed publications and produce formal presentations for national and international professional meetings
• Ability to travel nationally and internationally to field sites and meetings as needed.

In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately $270,000 - $310,000USD 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.

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