Senior Scientist or Principal Scientist – Pharmacology and Toxicology

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• Careers at VitriVax, Inc.
• Senior Scientist or Principal Scientist - Pharmacology & Toxicology

VitriVax, Inc. Senior Scientist or Principal Scientist - Pharmacology & Toxicology Boulder, CO

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VitriVax, Inc. is creating thermostable, single-injection vaccines using an innovative platform technology platform called ALTA®. Fundamentally, ALTA® products are formulations of antigens that use a manufacturing process combining particle engineering technologies from the pharmaceutical and semiconductor industries. Thermostable, single-injection products will revolutionize the vaccine industry and have attracted significant industry, government, and philanthropic interest. Learn more about VitriVax by visiting our website, https://vitrivaxbio.com/. If you are interested in joining VitriVax, Inc. we are always looking for talented individuals. Below is one opportunity to become a part of the team and work on this exciting new vaccine technology. See all open positions at VitriVax, Inc: HERE

About VitriVax, Inc.

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.

Description

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 i