Director, Compliance

Tonix Pharmaceuticals; United States; On-site; USD 180,000 - 210,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401k with company match

Stock options

Paid time off

Job summary

Tonix Pharmaceuticals is seeking a Director, Compliance to build and manage a program that supports a culture of ethics and regulatory excellence. You will report to the VP, Legal & Compliance and guide the organization in applying OIG guidance across seven elements of an effective compliance program.

You will draft policies, educate stakeholders, oversee monitoring for Commercial, Medical Affairs, and Market Access, and lead risk-based investigations.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years in-house compliance or related role in healthcare; or 8+ years with graduate degree.
• Direct compliance experience in the pharmaceutical or medical device industry.
• Direct experience building programs and selecting and managing vendors.
• Direct experience leading significant programs and projects.
• Experience managing compliance programs, including drafting policies and conducting investigations.
• Ability to implement risk-based analysis and drive process improvements with tech solutions.

Responsibilities

• Provide strategic direction across all seven OIG elements of an effective compliance program.
• Lead the development and education of healthcare compliance policies for stakeholders.
• Draft, implement, and maintain compliance policies, procedures, and work instructions.
• Oversee engagements with healthcare professionals and external funding in collaboration with stakeholders.
• Design and oversee a comprehensive compliance monitoring program with risk-based activities.
• Develop and deliver compliance training programs for employees.
• Lead transparency reporting programs (Open Payments) and cross-functional reporting processes.
• Maintain knowledge of applicable laws, regulations, and guidance affecting the program.

Skills

Compliance leadership

Risk assessment

Policy development

Training delivery

Vendor management

Cross-functional collaboration

Education

Bachelor's degree

MS/JD/MBA or advanced degree

Tools

Dashboards

Portals

Job description

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

The 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 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

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 sponsorships 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 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

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 programs and selecting and managing vendors
• Direct experience leading significant programs and projects
• Experience managing compliance programs, including drafting policies, developing and implementing training standards, leading 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 drive the implementation of technical solutions (e.g., dashboards, portals) to manage processes including the HCP and patient engagement processes; monitoring; investigations workflows
• 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

Salary Range $180,000 — $210,000 USD
* 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

• 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.