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
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-$380,000 USD
*Please note that Tonix does not offer sponsorship for this role.Recruitment & Staffing AgenciesTonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.
Compensation & BenefitsTonix provides a comprehensive compensation and benefits package which includes:
- 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
