Position Overview

Translational lead responsible for the strategic direction and integration of research, translational science, and nonclinical development across the Tonix portfolio. Oversee translational strategy, and GLP/non-GLP development activities to advance programs from target validation through IND, clinical development, and life-cycle management.

Key Responsibilities

• Provide scientific leadership across drug discovery, translational research, and nonclinical development to ensure seamless progression from target identification through candidate selection and IND-enabling studies.
• Partner with leadership to evaluate novel targets, mechanisms of action, biomarkers, and translational strategies that support portfolio prioritization and candidate selection.
• Guide target validation, pharmacology, proof-of-concept, and candidate-enabling invitro and invivo studies for small molecules, biologics, and vaccines.
• Develop integrated discovery-to-development strategies that leverage target’s biology, pharmacology, toxicology, and translational activities to reduce development risk.
• Lead translational science strategies that connect preclinical pharmacology, biomarkers, and mechanism of action with clinical development plans.
• Oversee development and implementation of biomarker strategies supporting pharmacodynamic assessments, patient selection, and clinical proof-of-mechanism.
• Collaborate with Clinical Development and Clinical Pharmacology to ensure nonclinical findings inform dose selection, clinical endpoints, and regulatory strategy.
• Drive integration of translational data across discovery, nonclinical, and clinical teams to improve decision-making and probability of technical success.
• 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 toxicology study design, execution, analysis and reporting for both non-GLP and GLP studies
• Oversee bioassay development and validation for all GLP/GCP Nonclinical and Clinical 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
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Qualifications

• PhD, PharmD, DVM, MD, or equivalent doctoral degree in pharmacology, toxicology, neuroscience, or a related discipline required. DABT certification is preferred.
• Minimum 15 years of progressive experience in pharmaceutical or biotechnology research and development, including drug discovery, translational science, and nonclinical development with 5+ years in leadership or executive role
• Demonstrated success leading programs from target identification and validation through candidate selection, IND-enabling studies, and clinical development.
• Significant experience developing translational strategies that connect disease biology, pharmacology, biomarkers, and clinical development.
• Experience leading multidisciplinary research, translational, and nonclinical organizations.
• Proven ability to integrate pharmacology, toxicology, DMPK, biomarkers, and regulatory strategy into cohesive development plans.
• Excellent written and verbal communication skills; capable of influencing executive teams and external stakeholders
• Prefer exposure to pharmacovigilance/safety risk management in clinical development
• Experience supporting regulatory interactions including Pre-IND, IND, End-of-Phase, and global health authority meetings.
• Experience managing internal teams and external vendors (CROs, consultants) in a matrixed, cross-functional environment
• Broad expertise in drug discovery, translational medicine, and nonclinical development
• Strong understanding of pharmacology, toxicology, DMPK, and biomarker development
• Experience integrating discovery biology with regulatory nonclinical development.
• Strategic portfolio leadership and program prioritization
• Scientific leadership in cross-functional matrix organizations
• Strong regulatory knowledge supporting IND, CTA, NDA, and BLA submissions
• Excellent communication skills with executive leadership, regulatory agencies, investors, and external collaborators
• Ability to travel to internal sites and other business needs +20% depending on location leadership in accordance with company policies and employment laws
• Track record of strategic portfolio leadership, due diligence, and scientific evaluation of external assets.