VP, Translational Science (Nonclinical) Development

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.