---
title: 'Director, Clinical Development at Tonix Pharmaceuticals'
canonical: 'https://feeny.ai/job/director-clinical-development-tonix-pharmaceuticals-berkeley-heights-nj-or-zmqzqefrmsjq'
type: 'job'
last_seen: '2026-11-11'
---

# Director, Clinical Development at Tonix Pharmaceuticals 

- **Company:** Tonix Pharmaceuticals 
- **Location:** Berkeley Heights NJ OR Frederick, MD
- **Compensation:** $190k–$240k
- **Posted:** 2026-11-09
- **Last confirmed live:** 2026-11-11
- **Apply:** https://job-boards.greenhouse.io/tonixpharmaceuticals/jobs/4477296009

## 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

The Director, Clinical Development provides medical and scientific leadership across clinical development programs, supporting the design, execution, and oversight of clinical trials from Phase 1 through Phase 3. This role combines strategic clinical development responsibilities with hands-on medical monitoring to ensure patient safety, scientific integrity, regulatory compliance, and high-quality clinical data.

The Director serves as the primary Medical Monitor for assigned studies, providing timely medical guidance to investigators, clinical sites, CROs, and internal study teams. Working closely with Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, Regulatory Affairs, and other cross-functional partners, this individual contributes to clinical development strategy while maintaining direct involvement in study execution, safety oversight, and emerging clinical data.

Guided by Tonix's core values of integrity, commitment, innovation, and passion, the Director applies sound clinical judgment, scientific expertise, and collaborative leadership to advance development programs and support the delivery of innovative therapies to patients.

## Key Responsibilities

Clinical Development and Study Strategy

- Provide medical and scientific leadership in the strategic planning, design, and execution of clinical development programs from Phase 1 through Phase 3.
- Contribute to clinical development strategies, study design, and future clinical program planning to support organizational objectives.
- Provide medical and scientific input into clinical trial protocols, eligibility criteria, endpoints, study assessments, and other measures supporting patient safety and scientific integrity.
- Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Nonclinical, CMC, and Commercial, to align clinical development activities with program objectives.
- Review and interpret clinical trial results to support development decisions, regulatory strategies, and future studies.

Medical Monitoring and Patient Safety

- Serve as the primary Medical Monitor for assigned clinical trials, providing direct medical oversight throughout study conduct.
- Provide timely medical guidance to investigators, study sites, CROs, and internal teams regarding patient eligibility, dosing, protocol requirements, safety events, and other study-related medical questions.
- Review and assess adverse events (AEs) and serious adverse events (SAEs), including causality, severity, expectedness, clinical significance, and potential impact on patient safety.
- Review patient-level and aggregate clinical and safety data, including laboratory results, eligibility assessments, protocol deviations, and emerging safety trends.
- Develop, review, and maintain study-specific Medical Monitoring Plans and ensure medical monitoring activities are appropriately documented.
- Collaborate with Pharmacovigilance to evaluate potential safety signals and determine appropriate follow-up, escalation, or additional surveillance.
- Review clinical data listings to identify medical inconsistencies, emerging trends, and issues requiring further investigation.
- Support Data Monitoring Committees and Data Safety Monitoring Boards, as applicable.
- Provide clinical training and ongoing medical guidance to investigators, study teams, and site personnel.

Regulatory and Scientific Activities

- Author, review, and provide medical and scientific input into clinical and regulatory documents, including protocols, investigator brochures, informed consent materials, clinical study reports, INDs, CTAs, and regulatory briefing documents.
- Participate in regulatory interactions with the FDA, EMA, and other global health authorities, including preparation and presentation of clinical data and responses to regulatory questions.
- Collaborate with internal and external stakeholders to address clinical and regulatory issues and support development milestones.
- Contribute to scientific publications, presentations, and medical or scientific congress activities, as appropriate.

Cross-Functional Collaboration and Leadership

- Partner with Clinical Operations and other functional teams to resolve medical and operational issues and support high-quality clinical trial execution.
- Build and maintain effective relationships with investigators, key opinion leaders, external medical experts, CROs, and clinical development partners.
- Provide medical and scientific guidance to clinical research professionals and cross-functional study teams.
- Mentor and support the professional development of clinical team members, as applicable.
- Promote collaboration, accountability, and continuous improvement across clinical development activities.

## Qualifications

- MD, DO, or equivalent medical degree required.
- Minimum of 7 years of relevant clinical development and/or medical monitoring experience within the pharmaceutical, biotechnology, or clinical research industry.
- Direct, hands-on experience serving as a Medical Monitor for industry-sponsored clinical trials required.
- Demonstrated ability to independently make medical decisions and serve as the primary Medical Monitor for assigned studies.
- Experience supporting Phase 1 through Phase 3 clinical trials.
- Experience with clinical trial design, protocol development, clinical data review and interpretation, and clinical study documentation.
- Strong knowledge of Good Clinical Practice (GCP), clinical trial safety reporting requirements, applicable regulatory guidelines, and clinical documentation standards.
- Clinical and Medical Expertise
- Strong experience reviewing and assessing AEs, SAEs, clinical laboratory data, patient eligibility, protocol deviations, and emerging clinical and safety information.
- Experience responding directly to investigator and site medical questions and providing timely medical guidance throughout study conduct.
- Excellent clinical judgment with the ability to independently evaluate complex medical information, recognize potential safety signals, and determine appropriate escalation or follow-up.
- Ability to interpret clinical and safety data and translate findings into actionable medical and scientific recommendations.
- Leadership and Communication
- Proven ability to collaborate effectively with multidisciplinary teams and provide medical leadership across clinical development activities.
- Strong analytical, organizational, communication, and problem-solving skills.
- Ability to communicate complex medical and scientific information clearly to investigators, study teams, regulatory authorities, and other stakeholders.
- Ability to work independently, manage competing priorities, and adapt to evolving clinical development needs in a fast-paced biopharmaceutical environment.
- Preferred Qualifications
- Experience supporting later-stage clinical development programs.
- Experience with regulatory submissions and interactions involving the FDA, EMA, or other global health authorities.
- Therapeutic area experience relevant to Tonix's development programs, including rheumatology, oncology, infectious disease, vaccines, and/or biologics.
- Previous experience providing clinical development leadership and mentoring clinical research professionals.
- Experience contributing to scientific publications, presentations, or regulatory development strategies.

Salary Range $190,000—$240,000 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, 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

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