Director, Compliance
Listed on 2026-10-12
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Business
Regulatory Compliance Specialist
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 and follow the Company on Linked In and X.
* 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 Sym Touch 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 OverviewThe Director, Compliance reports to the VP, Legal & 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
Key Responsibilities- Provide strategic direction across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices
- Assume primary responsibility for all healthcare compliance policies and educating business stakeholders in their application
- Working collaboratively, draft, implement, administer and maintain relevant compliance policies, procedures, and work instructions
- Management and oversight of
1) engagements with healthcare professionals and patients including FMV and
2) external funding (including sponsor ships and grants) in collaboration with relevant stakeholders - Assist with designing 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 training plans and deliver effective compliance training programs to employees, enhancing awareness and understanding of ethical standards and legal obligations.
- Lead the ongoing oversight of federal and state transparency reporting programs, including Open Payments (Sunshine Act) and state-specific disclosure requirements. Collaborate cross-functionally with Legal, Finance, Medical Affairs, and Commercial teams to build scalable processes that support transparency, mitigate risk, and promote ethical business practices.
- Maintain a current working…
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