Eliminating Barriers to Global Vaccination VitriVax, Inc. is a formulation technology company engineering innovative solutions to maximize global accessibility and utility of human and animal vaccines – vaccines that save lives and protect our world from preventable disease.

VitriVax is seeking an accomplished Senior Scientist or Principal Scientist in Pharmacology & Toxicology to lead and execute IND-enabling nonclinical safety and toxicology studies in support of new investigational candidates to support their clinical development. The ideal candidate will bring deep expertise in vaccine pharmacology, immunotoxicology, histopathology and general safety and tolerability, with a experience in generating, interpreting, and documenting nonclinical data to support U.S. FDA regulatory submissions. The role reports to the Head of Preclinical Research and will represent Preclinical Research in a matrix product development team. This role will work cross-functionally with product formulation, analytical, CMC, regulatory and clinical development teams and will serve as a key scientific contributor to safety and tolerability strategy, non-cGLP and GLP safety studies, pre-IND and IND documentations, and interactions with external CROs and partners.

 

Responsibilities and Duties:

Nonclinical Pharmacology & Toxicology

• Design, oversee, and interpret IND-enabling general safety and tolerability studies for new product candidates, including single- and repeat-dose toxicology, reprotox, genotox, pharmacology, PK/ADME, and local and systemic tolerability studies.
• Develop nonclinical strategies aligned with ICH, FDA, and WHO guidance for prophylactic vaccines and novel delivery platforms.
• Assess vaccine safety, biodistribution, and immune-related risks to recommend dose range selection  and provide inputs for safety primary and secondary endpoints in early Phase I/II clinical trial design.
• Provide expert opinion and recommendations to project team and senior management on safety and tolerability study interpretations and risks for new investigational products.

 

Regulatory & IND Support

• Ensure all safety and tolerability studies are conducted in appropriate model species and in compliance with company and regulatory guidelines.
• Author and review nonclinical pharmacology, ADME/PK (metabolism), and toxicology study sections of INDs and briefing packages, including supporting study reports, summaries, and investigator brochures.
• Serve as a nonclinical pharmacology and toxicology subject-matter expert in interactions with regulatory agencies.

 

Study Execution & Partner Management

• Manage and oversee outsourced pharmacology and toxicology studies at CROs and academic collaborators.
• Provide scientific oversight for protocol design and development, data review and appropriate interpretation, and final documentation of all study reports.
• Troubleshoot study execution challenges ensuring timelines and quality standards are met.

 

Cross-Functional Collaboration

• Collaborate with formulation, analytical, and CMC teams and the project leader to align on nonclinical safety and tolerability strategy and conduct studies aligned with product development and manufacturing changes.
• Contribute to overall project team decision-making by integrating pharmacology and general safety and tolerability risk assessments and providing appropriate mitigation strategies.
• Mentor junior scientists and contribute to the growth of nonclinical capacities and capabilities within VitriVax.

 

Education and Experience

 Required

• Ph.D. in Pharmacology, Toxicology, Immunology, or a related life sciences discipline
• Demonstrated hands-on expertise in vaccine pharmacology, toxicology, and immunology
• Experience authoring, managing, and adhering to IACUC protocols
• Experience with common laboratory data software including statistical analysis
• Experience in IND-enabling general safety and tolerability studies to support clinical development of vaccine candidates
• Demonstrated experience of working with CROs in managing cGLP safety and tolerability studies

 

Preferred

• Experience with novel vaccine platforms, adjuvants, or delivery technologies
• Familiarity with thermostable formulations or non-traditional vaccine manufacturing approaches and their safety and tolerability assessments
• Prior involvement in regulatory interactions with CBER/CDER FDA or other global health authorities
• Experience authoring nonclinical sections and supporting IND submissions.
• Demonstrated ability to work effectively in small, fast-paced biotech environments.

 

Core Skills and Competencies

All VitriVax employees are expected to share the following values and skills.

Integrity

We are team players who say what we do and do what we say. We respect our obligations and are transparent in our communication. We present all data factually. When presented with ambiguous situations, we strive to do the right thing.

Innovation

We create value by developing superior products and processes. We have a curious mindset, apply an analytical approach and take calculated risks. We take on difficult problems and break barriers.

Passion

We are passionate about making vaccines accessible to everyone. We share our enthusiasm with purpose. We are never satisfied with the status quo and want to make a difference.

Quality

We seek quality information, decisions and people. We put safety first and approach every opportunity with a right first-time mindset that is focused on the end goal. We are committed to continuous improvement and elimination of waste.

Salary and Benefits

The salary will be determined by the applicant’s experience and alignment with current and future responsibilities. 

• Senior Scientist:           PhD with +5 years’ relevant experience
• Principal Scientist:       PhD with +7 years’ relevant experience

 

Salary Range DOE - $130K - $200K

 

All full-time employees are eligible for the following benefits.

·      Stock options

·      401(k) with generous Company match

·      Flexible work schedule

·      Health, Dental and Vision insurance

·      Short and Long Term Disability insurance

 

VitriVax, Inc., is an Equal Opportunity Employer and does not discriminate based on race, color, gender, sexual orientation, gender identity or expression, religion, disability, national origin, protected veteran status, age, or any other status protected by applicable national, federal, state, or local law.

 

VitriVax, Inc., requires all staff to be vaccinated against communicable diseases as recommended by the CDC prior to employment.