Director, Compliance

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 Zace® Sym Touch® (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, 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  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.

The Director, Compliance reports to the Head of Commercial Legal and Compliance and supports the function in developing, implementing, and maintaining an effective Compliance Program that (1) supports and promotes a company wide culture of ethics and compliance, and (2) meets or exceeds applicable regulatory standards for effective compliance programs, including the Office of Inspector General (OIG) Guidance.

• Assume primary responsibility for all compliance policies and educating business stakeholders in their application;
  Working collaboratively, draft, implement, administer and maintain relevant compliance policies, procedures, work instructions, and training programs.
• Assist with providing strategic direction across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices.
• Manage and implement compliance guidance related to engagements with healthcare professionals, as well as policies related to clinical studies, sponsor ships, and grants.
• Lead the development, implementation, and ongoing oversight of federal and state transparency reporting programs, including Open Payments (Sunshine Act) and state‑specific disclosure requirements. Ensure timely and accurate data collection, validation, and submission in alignment with regulatory expectations and internal compliance standards. Collaborate cross‑functionally with Legal,, Medical Affairs, and Commercial teams to build scalable systems and processes that support transparency, mitigate risk, and promote ethical business practices.
• Assist with designing, implementing, and overseeing a comprehensive compliance monitoring program to assess adherence to internal policies, regulatory requirements, and industry standards. Lead risk‑based monitoring activities across key business functions, including Commercial, Medical Affairs, and Market Access, to proactively identify and mitigate compliance risks. Develop actionable insights from monitoring outcomes, drive continuous improvement, and ensure timely reporting and remediation in collaboration with cross‑functional stakeholders.
• Develop and deliver effective compliance training programs to employees, enhancing awareness and understanding of ethical…