--- title: 'VP, Translational Science (Nonclinical) Development at Tonix Pharmaceuticals' canonical: 'https://feeny.ai/job/vp-translational-science-nonclinical-development-tonix-pharmaceuticals-berkeley-5s2mjnnmwgjk' type: 'job' last_seen: '2026-10-28' --- # VP, Translational Science (Nonclinical) Development at Tonix Pharmaceuticals - **Company:** Tonix Pharmaceuticals - **Location:** Berkeley Heights NJ OR Frederick, MD - **Compensation:** $285k–$380k - **Posted:** 2026-07-15 - **Last confirmed live:** 2026-10-28 - **Apply:** https://job-boards.greenhouse.io/tonixpharmaceuticals/jobs/4289636009 ## 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](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D9p5FBvlzG2u-9NzVEDdUgRNdl57Mw08p4h9XviYYnbwVJ-X_DNEOeN4RdGA64IhTnk9R4lQWNXhq0g8TrvoRTCZSpqmowBapMZCbqP_sxm0%3D&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987080441%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=WrmW8ZuY9XRYJZM0BMPu3thoab5uVHnt9SqBNHIoDuU%3D&reserved=0) and follow the Company on [LinkedIn](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbldblPUeLBo2VtrimIDsthVk4RaPH1sCjnDw18J2Q9UGKOYpi7kKsd6NuJ4rb7a1ocGevguAt4l_8t8TE5rfCP1YmSBTJO1HR9Uo9KAv_DEwtbEkJhm1CdLRAEbAUNB-&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987109283%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=dHRzyv5dfKFOhCroh809txjNcJOjNrBSQRyfSgHaIu8%3D&reserved=0) and [X](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D0NgIEJjy96AytWlfgCqgqVv5cOeUVkGOTFS78koSy22XXOczOtXjxSorNUcN-uDTk4CYVQkJndgCk6o2RQBlKQ%3D%3D&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987130654%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=frLcoK5ETOWzJq9lmvkirCS8HaHc2WCX%2Fg4ESMSdLgk%3D&reserved=0). *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 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 Agencies Tonix 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 & Benefits Tonix 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 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 expressly 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. ## About Tonix Pharmaceuticals ## Company Overview - **One-liner**: A fully-integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system disorders, immunology, infectious diseases, and rare diseases. - **Entity Type**: Public (NASDAQ: TNXP) - **Headquarters**: Berkeley Heights, New Jersey, United States (as indicated by zip code 07922 on the investor relations page) [ir.tonixpharma.com](https://ir.tonixpharma.com/) - **Founded**: Not publicly available from provided sources - **Founders**: Not publicly available from provided sources ## Core Business - **Primary industry/industries**: Biotechnology / Pharmaceuticals (therapeutics) - **Target customers**: B2B – physicians (rheumatology, primary care, pain management, neurology), hospitals, specialty distributors, and patients through prescription-based access. - **Mission or purpose statement**: “We listen, we develop, we deliver – so that patients feel seen, heard, and empowered to live fully again.” [tonixpharma.com](https://www.tonixpharma.com/) ## Products & Services - **TONMYA® (cyclobenzaprine HCl sublingual tablets)**: Approved in the U.S. (August 2025) and launched in November 2025 for the treatment of fibromyalgia in adults – the first new medicine for fibromyalgia in over 15 years. Non-opioid, centrally acting analgesic designed for bedtime dosing. [tonixpharma.com](https://www.tonixpharma.com/) - **Zembrace® SymTouch® (sumatriptan injection)**: FDA-approved prescription product for the treatment of acute migraine. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **Tosymra® (sumatriptan nasal spray)**: FDA-approved prescription product for acute migraine. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-102 SL (cyclobenzaprine HCl sublingual tablets)**: Investigational for Major Depressive Disorder (Phase 2 planned mid-2026) and Acute Stress Disorder/Reaction (Phase 2 enrolling, OASIS study at UNC funded by DoD). [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-4800 (anti-OspA monoclonal antibody)**: Seasonal prevention of Lyme disease – Phase 2 field study planned first half 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-1500 (humanized anti-CD40L mAb)**: Phase 2-ready for prevention of kidney transplant rejection (investigator-initiated study expected mid-2026) and treatment of autoimmune diseases. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-1300 (double-mutant cocaine esterase)**: Phase 2 for cocaine intoxication; FDA Breakthrough Therapy designation. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-2900 (intranasal oxytocin + magnesium)**: For Prader-Willi Syndrome – Orphan Drug and Rare Pediatric Disease designations; Phase 2 planned Q1 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-801 (horsepox live virus vaccine)**: Preclinical – mpox/smallpox protection; Phase 1 expected in 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-4200 (small molecule anti-CD45)**: Broad-spectrum antiviral for biodefense; preclinical, supported by up to $34M DoD contract. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-1700 (TFF2-albumin fusion)**: Preclinical for gastric/colorectal cancer in combination with PD-1 blockade (in-licensed from Columbia University). [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) - **TNX-4900 (Sigma-1 receptor antagonist)**: Preclinical non-opioid analgesic for neuropathic pain. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf) ## Market Standing - **Valuation/Market Cap**: Not publicly available from provided sources (public stock; market cap fluctuates) - **Key Metric**: Annual Revenue – Not disclosed in provided sources (commercial launch of TONMYA began November 2025; earlier revenue from Zembrace/Tosymra). Total funding rounds not applicable for public company. R&D expenditures detailed in 10-K but not extracted. - **Notable Investors/Partners**: Almac Pharma Services (commercial supply for TONMYA) [10-K]; U.S. Department of Defense (DTRA contract up to $34M for TNX-4200) [10-K]; University of North Carolina (OASIS study for TNX-102 SL) [10-K]; Columbia University (TNX-1700 in-license) [10-K]. - **Growth Signals**: First FDA approval and launch of internally developed drug TONMYA (Nov 2025); expanding commercial payer coverage (second commercial agreement covering ~52M U.S. lives) [tonixpharma.com]; multiple Phase 2 programs advancing; ownership of two manufacturing facilities (RDC in Frederick, MD and ADC in Dartmouth, MA) [10-K]. ## Competitive Advantages - **First-mover in fibromyalgia**: TONMYA is the first new FDA-approved treatment for fibromyalgia in 15+ years, with a proprietary sublingual formulation that offers differentiated bioavailability and tolerability. - **Broad, diversified pipeline**: Covers CNS, immunology, infectious disease, and rare disease – reducing single-program risk and providing multiple shots on goal. - **In-house manufacturing**: Owned R&D Center (Frederick, MD) with BSL-2/3 capability and an Advanced Development Center (Dartmouth, MA) for live-virus vaccine and biologics production (currently decommissioned but ready for reactivation) [10-K]. - **Non-opioid focus**: All analgesic candidates (TONMYA, TNX-4900) are non-opioid, aligning with regulatory and societal trends away from opioids. - **Government partnerships**: DTRA contract for biodefense work (TNX-4200) provides non-dilutive funding and mission relevance. ## Strategic Focus - **Grow TONMYA**: Expand commercial coverage, physician adoption, and patient access for fibromyalgia treatment. - **Advance pipeline**: Initiate or complete Phase 2 studies for TNX-102 SL (MDD, ASD), TNX-4800 (Lyme), TNX-1500 (transplant rejection), TNX-1300 (cocaine intoxication), TNX-2900 (Prader-Willi), and move TNX-801 (mpox/smallpox vaccine) into Phase 1. - **Pursue strategic business development**: In-licensing, partnerships, and potential acquisitions to augment pipeline and commercial portfolio [10-K]. ## Why Work Here - **Culture**: The company emphasizes a collaborative, inclusive environment where every voice is heard. Mission-driven focus on “listening to patients’ lived experiences” and developing therapies for underserved, complex conditions. [tonixpharma.com/careers](https://www.tonixpharma.com/careers/) - **Work model**: Information on remote/hybrid policy not publicly available. Office and lab facilities in Berkeley Heights, NJ (HQ), Frederick, MD (R&D Center), and Dartmouth, MA (Advanced Development Center). - **Team & growth**: Opportunity to work on first-in-class drug launches (TONMYA) and cutting-edge science across multiple therapeutic areas. The company is at a pivotal stage transitioning from pure R&D to a commercial organization, offering varied career pathways. - **Benefits**: Equal opportunity employer; does not offer visa sponsorship for open positions. [tonixpharma.com/careers](https://www.tonixpharma.com/careers/) - **Notable perks/engineering culture**: Not detailed, but the science-driven environment with in-house manufacturing and government-funded biodefense work may appeal to researchers and engineers in pharma. ## Sources 1. [tonixpharma.com](https://www.tonixpharma.com/) – Company homepage, mission, product info, lat _…truncated._ ## Other roles at Tonix Pharmaceuticals - [Director, Quality Assurance Operations](https://feeny.ai/job/director-quality-assurance-operations-tonix-pharmaceuticals-berkeley-heights-nj-frckx0qmageg) — Berkeley Heights NJ OR North Dartmouth, MA - [Director, Compliance](https://feeny.ai/job/director-compliance-tonix-pharmaceuticals-berkeley-heights-e4863q314xb1) — Berkeley Heights, NJ - [Regional Sales Director - Florida](https://feeny.ai/job/regional-sales-director-florida-tonix-pharmaceuticals-florida-vp0q9e3e00rs) — Florida - [Senior Clinical Project Manager](https://feeny.ai/job/senior-clinical-project-manager-tonix-pharmaceuticals-berkeley-heights-v6zs7ea8q265) — Berkeley Heights, NJ - [Senior Internal Auditor - SOX Compliance](https://feeny.ai/job/senior-internal-auditor-sox-compliance-tonix-pharmaceuticals-berkeley-heights-5s2s64ygvz1q) — Berkeley Heights, NJ - [Associate Director, Commercial Analytics & Sales Force Effectiveness](https://feeny.ai/job/associate-director-commercial-analytics-sales-force-effectiveness-tonix-21gmwfrwft16) — Berkeley Heights, NJ