Study Director

Job Description

Job Description

About Tonix*

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.

Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.

Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

Please visit www.Tonixpharma.com for specifics on the pipeline.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix Pharmaceuticals seeks a highly experienced and mission-driven Study Director for cross-functional in-vivo and in-vitro pharmacological studies for our growing portfolio of vaccines and therapeutics in oncology, infectious diseases, immunology and CNS disease. This position will play a key strategic role in advancing Tonix’s diversified pipeline of candidates. This includes supporting research and advanced development across small molecules and biologics that target immune pathways, inflammation, CNS disorders, and infections. The Study Director will work with a team of scientists and oversee the integration of various preclinical and IND enabling studies including molecular, virologic, microscopic, biochemical, and immunologic assays, and will be responsible for drafting study designs and protocols, coordinating data collection and analysis, and generating conclusive study reports for advancing candidate into clinic. The quality of the study and reporting must be at the level for submission to the FDA and other regulatory agencies.

The ideal candidate will have extensive experience in animal research, peer-reviewed publication, must be well experienced in well-documented studies, GLP compliance, and scientific leadership within government, academic, or industry settings. This is a fast-paced challenging position offering competitive compensation and benefits package. This position will report to the Director, In-vivo Sciences and Comparative Pathology and will be based at the Tonix Research and Development Center in Frederick, Maryland.

Key Responsibilities:

• Serve as a Study Director on various projects across Tonix’s preclinical/research and development portfolio.
• Write and oversee in-vivo and/or in-vitro study protocols.
• Oversee study planning, scheduling, and staffing requirements.
• Monitor study timelines and ensure achievement of pre-established project milestones.
• Write and collate study reports, manuscripts, and data summaries for assigned projects.
• Ensure compliance with regulatory guidelines and internal SOPs.
• Publish research results in peer-reviewed national and international journals, and present research data in various internal and external forums.
• Coordinate research collaborations with multiple disciplines, academic institutions, industry, and government agencies.
• Collaborate with Tonix’s Discovery, Regulatory, and Clinical teams to ensure alignment of pre-clinical models with translational objectives.
• Participate as a team member to coordinate with toxicology, DMPK, and higher tiered toxicology programs.

Qualifications:

• Ph.D., D.V.M., or other professional degree with a focus in biomedical sciences
• Minimum 10 years of experience with pre-clinical and/or translational research
• Outstanding communication, leadership, and cross-functional coordination skills required.
• Demonstrated expertise in animal research and examination of therapeutics and vaccine research.
• Prior experience leading GLP and non-GLP preclinical programs in pharmaceutical industry or government institutions.
• Prior experience with laboratory information management systems (LIMS).
• Familiarity with drug screening assay development and analysis.
• Demonstrated expertise in IND-enabling studies and participation with IACUC activities and/or facility veterinary functions preferred.

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

Annualized base salary ranges from $150,000 to $200,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit.

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.