Director, Compliance
Tonix Pharmaceuticals
Director, Compliance
Tonix Pharmaceuticals
Clinical-stage biopharma in CNS and vaccines
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 and follow the Company on LinkedIn 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 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
Help shape a culture where integrity guides decisions and compliance supports responsible growth.
The Director, Compliance reports to the VP, Legal & Compliance and supports the function in developing, implementing, and strengthening an effective Compliance Program that (1) champions a companywide culture of ethics and compliance, and (2) meets or exceeds applicable regulatory standards for effective compliance programs, including Office of Inspector General (OIG) guidance. Guided by Tonix’s core values of integrity, commitment, innovation, and passion, this role partners across the organization to translate complex requirements into practical solutions, empower informed decision-making, and advance responsible business practices.
Key Responsibilities
Shape strategic direction across all seven OIG elements of an effective compliance program, drawing on industry best practices to strengthen program effectiveness.
Take primary ownership of healthcare compliance policies and equip business stakeholders to understand and apply them with confidence and integrity.
Collaborate across functions to develop, implement, administer, and maintain clear, practical compliance policies, procedures, and work instructions.
Oversee engagements with healthcare professionals and patients, including fair market value (FMV) assessments, and external funding activities, including sponsorships and grants, in partnership with relevant stakeholders.
Help design and oversee a comprehensive compliance monitoring program to assess adherence to internal policies, regulatory requirements, and industry standards. Lead risk-based monitoring across Commercial, Medical Affairs, and Market Access to proactively identify and mitigate compliance risks. Translate findings into actionable insights, drive continuous improvement, and ensure timely reporting and remediation in collaboration with cross-functional stakeholders.
Develop training plans and deliver engaging, practical compliance training that empowers employees to understand and apply ethical standards and legal obligations in their daily work.
Lead ongoing oversight of federal and state transparency reporting programs, including Open Payments (Sunshine Act) and state-specific disclosure requirements. Partner with Legal, Finance, Medical Affairs, and Commercial teams to build scalable processes that strengthen transparency, mitigate risk, and reinforce ethical business practices.
Stay current on laws, regulations, and industry guidance affecting the Compliance Program and translate developments into practical guidance. Areas include anti-kickback and fraud and abuse laws, anti-bribery and anti-corruption requirements, transparency laws, price reporting, OIG and DOJ guidance, and industry standards such as the PhRMA Code.
Qualifications
Bachelor’s degree.
MS, JD, MBA, or other relevant advanced degree strongly preferred.
10+ years (with a B.S. degree), or 8+ 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.
Direct experience building and strengthening programs and selecting and managing vendors.
Direct experience leading significant programs and projects from planning through execution.
Experience managing compliance programs, including drafting policies, developing and implementing training standards, leading monitoring initiatives, and conducting investigations involving sensitive matters.
Ability to apply risk-based analysis to legal and compliance issues and develop innovative, practical solutions that satisfy both business requirements and legal obligations.
Ability to drive implementation of technical solutions, such as dashboards and portals, to streamline healthcare professional (HCP) and patient engagement processes, monitoring activities, and investigation workflows.
Ability to translate complex compliance concepts into clear, actionable guidance connected to business objectives.
Strong oral, written, and presentation skills with exceptional attention to detail.
Demonstrated initiative, sound judgment, and a proactive approach; ability to work independently and collaboratively, build trusted internal and external relationships, and follow through on commitments.
Demonstrated alignment with Tonix’s core values: integrity in judgment and conduct, commitment to accountability and follow-through, innovation in problem-solving, and passion for advancing a culture of ethics and compliance.
*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:
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.
Salary Range 180000 - 210000 USD
Clinical-stage biopharma in CNS and vaccines
Tonix Pharmaceuticals develops therapeutics and biologics for CNS disorders, rare diseases, immunology, and infectious diseases. Its products include Zembrace SymTouch and Tosymra for acute migraine, providing near-term revenue while it advances a pipeline across CNS conditions like fibromyalgia with Tonmya (TNX-102 SL); infectious disease vaccines from a horsepox-based platform led by TNX-801 for smallpox and mpox; and immunology programs for transplant rejection, autoimmunity, and cancer. The company aims to move candidates through clinical trials to regulatory approval and commercialization, using partnerships to grow its long-term portfolio. By mixing established migraine meds with a diversified, research-driven pipeline, Tonix targets recurring revenue now and growth in CNS, infectious disease, and immunology over time.
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