ABOUT TONIX*

Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases.

POSITION OVERVIEW

GLP Nonclinical Lead responsible for the execution and oversight of all GLP studies for Tonix programs. This role can be based in Frederick, Maryland or at Tonix Headquarters in New Jersey.

NECESSARY SKILLS AND ABILITIES

• Demonstrated leadership in preparing and defending regulatory submissions (IND, NDA, BLA) and engaging with global regulators
• Experience managing internal teams and external vendors (CROs, consultants) in a matrixed, cross-functional environment
• Excellent written and verbal communication skills; capable of influencing executive teams and external stakeholders
• Prefer exposure to pharmacovigilance/safety risk management in clinical development
• Toxicology expertise

EDUCATIONAL AND EXPERIENCE REQUIREMENTS

• Doctor of Veterinary Medicine required; MS or PhD in toxicology or related field strongly preferred
• Board certification in toxicology (DABT) required or equivalent recognized credential
• Minimum 15 years of relevant experience in the biopharmaceutical industry with 5+ years in leadership or executive role
• Track record of success in Nonclinical strategy development and execution across multiple therapeutic areas and modalities

• Designing and implementing nonclinical development strategies to support early- and late-stage regulatory filings (INDs, CTAs, NDAs, BLAs) for all Tonix programs including small molecules, biologics and vaccines.
• Nonclinical study design, execution, analysis and reporting for both non-GLP and GLP studies
• Bioassay development and validation for all GLP Nonclinical studies
• Serve as the Nonclinical executive sponsor on cross-functional program teams, contributing to asset prioritization, risk mitigation, and go/no-go decisions
• Own Nonclinical content for regulatory submissions and meetings with global health authorities (FDA, EMA, etc.), including direct engagement with regulators
• Oversee the selection and management of CROs, ensuring scientific rigor, regulatory compliance (GLP), and budget alignment
• Manage Nonclinical adverse event reporting, both GLP and non-GLP in collaboration with Clinical and Regulatory functions
• Partner closely with Clinical, Regulatory, CMC, and research leadership to align nonclinical plans with overall program timelines and company goals
• Contribute to due diligence evaluations for in-licensing and M&A activities, including risk assessment of third-party nonclinical packages
• Support the development of intellectual property for Tonix programs
• Publish and present findings
• Manage Nonclinical budget for GLP and non-GLP studies in support of advancement of pipeline products through clinical development, marketing authorization, and throughout life cycle