Director of Compliance

About Tonix

Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases.

Position Overview

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 companywide 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.

Essential Functions

• 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, sponsorships, 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, Finance, 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 standards and legal obligations.

Necessary Skills and Abilities

• Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the compliance program, including antikickback and fraud and abuse laws, bribery and corruption, transparency laws, price reporting, OIG and DOJ guidelines, and industry standards, such as the PhRMA Code.
• Experience managing compliance programs, including drafting policies, implementing training standards, undertaking monitoring initiatives, and conducting investigations on sensitive matters.
• Ability to apply a risk-based analysis to legal and compliance issues and develop creative and practical solutions that satisfy both business requirements and legal obligations. Ability to manage and assist in the implementation of technical solutions to manage the HCP engagement processes.
• Communicates complex compliance concepts effectively to the organization in a way that is connected to business objectives.
• Strong oral, written and presentation communication skills with superior attention to detail.
• Demonstrates initiative and excellent judgment; proactive; ability to work independently and collaboratively within a team setting; able to build relationships, both internally and externally.
• Demonstrated commitment to compliance, ethics, integrity, accountability and innovation.

Educational Requirements

• Bachelor’s degree at minimum
• MS or JD degree strongly preferred

Experience Requirements

• 8+ years (with a B.S. degree), or 6+ years (with a graduate degree) of recent, relevant in-house experience in a compliance or related department of a healthcare organization or directly applicable law firm experience
• Direct compliance experience in the pharmaceutical or medical device industry

Compensation & Benefits

Annualized base salary ranges from $150k to $240k 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