VP, Translational Science (Nonclinical) Development

Tonix Pharmaceuticals; Frederick (MD); On-site; USD 285,000 - 380,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401k with company match

Stock options

Paid time off

Job summary

Tonix Pharmaceuticals is seeking a Translational Lead to steer research, translational science, and nonclinical development across its CNS and immunology portfolio.

You will oversee strategy, GLP/non-GLP activities, and IND-to-life-cycle management, coordinating with Clinical, Regulatory, CMC, and external partners to ensure robust, regulated program progression.

Qualifications

• PhD, PharmD, DVM, MD, or equivalent doctoral degree in pharmacology, toxicology, neuroscience, or a related discipline required.
• DABT certification is preferred.

Responsibilities

• Provide scientific leadership across drug discovery, translational research, and nonclinical development.
• Partner with leadership to evaluate targets, mechanisms, biomarkers, and translational strategies.
• Guide target validation, pharmacology, proof-of-concept, and enabling studies for various modalities.
• Develop integrated discovery-to-development strategies to reduce development risk.
• Lead translational science strategies linking preclinical to clinical plans.
• Oversee biomarker strategies supporting pharmacodynamics and patient selection.
• Collaborate with Clinical Development to align nonclinical findings with regulatory strategy.
• Drive integration of translational data across discovery, nonclinical, and clinical teams.
• Design nonclinical development strategies for INDs, CTAs, NDAs, and BLAs across programs.
• Oversee nonclinical tox study design, execution, and reporting (GLP and non-GLP).
• Manage bioassay development and validation for GLP/GCP studies.
• Serve as nonclinical executive sponsor on cross-functional teams.
• Own nonclinical content for regulatory meetings with FDA/EMA.
• Oversee CRO selection and budget alignment.
• Manage nonclinical adverse event reporting with Clinical/Regulatory teams.
• Coordinate with Clinical, Regulatory, CMC, and research leadership.
• Contribute to due diligence for in-licensing and M&A.
• Support IP development for Tonix programs.
• Publish and present findings.

Skills

Excellent written and verbal comms

Leadership & executive collaboration

Strategic portfolio leadership

Cross-functional leadership

Education

PhD/MD/PharmD/DVM or equivalent doctoral degree in related field

DABT certification preferred

Job description

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. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third‑generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader‑Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

• 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.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

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 in vitro and in vivo 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

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.

Salary Range: $285,000 USD - $380,000 USD

• Please note that Tonix does not offer sponsorship for this role.

Compensation & Benefits

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary stock options
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Career Development and Training

Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expresses prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.