Pharmacovigilance Director

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. 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 TLR3 agonists.

We are looking for a Pharmacovigilance Director to join our South San Francisco team. This is an onsite position in our South San Francisco Office.

The Pharmacovigilance Director is responsible for providing direction and oversight for all drug safety and pharmacovigilance activities, including signal detection/evaluation and risk management. The individual in this role will partner with the Chief Medical Officer (CMO) and Medical Monitor(s) to oversee all operational aspects for safety and pharmacovigilance, including development and implementation of relevant processes in compliance with local, regional, and global regulatory requirements and execution of these processes for all Vaxart's vaccine trials.

Responsibilities:

• Organizes and oversees medical reviews of individual case safety reports for serious adverse events (SAE) that occur at any of Vaxart's clinical trials. Reviews SAE reports, adhering to standard operating procedures for medical assessment of individual case safety reports providing medical safety assessments and pharmacovigilance comments. Triages the reports to medical staff as appropriate to ensure that all cases are analyzed, closed out and documented in compliance with GCP/ICH guidelines.
• Provides safety input to clinical development plans, study protocols, amendments, IB, ICF, CSR, responses to health authorities (HA) or institutional review board (IRB)/ ethics committee (EC) queries.
• Oversees, prepares, and/or reviews aggregate safety review documents (e.g., DSUR) and safety sections of relevant clinical trial documents (e.g., protocols, CSRs, IBs, ICFs and regulatory filings).
• Facilitates and ensures communication with functions involved with receiving, investigating, or reporting AE's is clear, accurate and effective; supports cross-functional study and program teams.
• Leads the evaluation and management documentation of signals emerging from any data source.
• Develops strategy for signal evaluations (e.g., case-series, literature review, HA/ claims database).
• Contributes to process improvement, particularly with adverse event processing and operational aspects of medical reviews.
• Coordinates and supports medical review meetings and other cross functional meetings on clinical safety with other groups as well as any relevant ad hoc safety related projects.
• Leads safety activities and benefit-risk strategies for assigned compounds/programs. Establishes and chairs the product Safety Management Teams as required.
• Assists the team and senior management in all forms of safety related issue management.

Requirements:

• MD or DO with active medical license and a minimum of 8 years of progressive clinical development experience in pharmacovigilance working with vaccines, at a pharmaceutical or biotechnology company or government agency.
• 10+ years of experience in pharmaceutical safety including a thorough understanding of safety operations and global regulatory requirements; and broad understanding of downstream activities including signal detection and risk assessment; 10-12+ years of industry experience required.
• A minimum of 5 years of project or line management experience overseeing PV staff and/or consultants/CRO's.
• 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.
• Broad experience in clinical trial design and safety implementation (Phase 1 to 3) and clinical data interpretation.
• Expert knowledge of global PV requirements, e.g., US Code of Federal (CFR) regulations, Good Pharmacovigilance Practices (GVP), FDA regulations, Office of Human Research Protections regulations, EMA/MHRA regulations and ICH/GCP Guidelines.
• Extensive working knowledge of MedDRA and Proprietary safety databases.
• Experience managing business processes and outsourcing vendors and relationships.
• Strong relationship building and collaboration skills, with the ability to interact effectively in a multifunctional, multicultural, growing organization.
• Highly self-motivated and comfortable operating in an entrepreneurial environment as a functional leader and as a member of a team.
• Ability to lead, operate and thrive in a fast-paced environment; demonstrated flexibility, attention to detail, and quality focus.
• Strong organizational, project management, technical and problem-solving skills.
• Well-developed presentation, communication, and interpersonal skills, including strong oral and written communication skills.

In accordance with California's Pay Transparency law, Vaxart's base salary range for this position is approximately $230,000 - $275,000USD 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.