VP, Translational Science (Nonclinical) Development

Tonix Pharmaceuticals•Frederick, MD

2d•$285,000 - $380,000•Onsite

About The Position

Tonix Pharmaceuticals is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. This position is for a Translational lead responsible for the strategic direction and integration of research, translational science, and nonclinical development across the Tonix portfolio. The role will oversee translational strategy, and GLP/non-GLP development activities to advance programs from target validation through IND, clinical development, and life-cycle management.

Requirements

PhD, PharmD, DVM, MD, or equivalent doctoral degree in pharmacology, toxicology, neuroscience, or a related discipline required.
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
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.
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
Track record of strategic portfolio leadership, due diligence, and scientific evaluation of external assets.

Nice To Haves

DABT certification is preferred.
Prefer exposure to pharmacovigilance/safety risk management in clinical development

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