BranchFactor Summary

The original posting with the fluff stripped out

Expected experience: 15+ yrs
Management level: People management
Visa sponsorship: Not offered

Compensation

No salary listed for this role.

Role speciality

Biomarker DevelopmentDrug DiscoveryNonclinical DevelopmentPharmacologyToxicologyTranslational Science

Required qualifications

Field of studyNeuroscience, Pharmacology, Toxicology (or related)

Study levelDoctorate

Preferred qualifications

CertificationsDABT

Original posting

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.

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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

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.