Director, Compliance
Listed on 2025-12-18
-
Management
Regulatory Compliance Specialist, HR Manager
Join to apply for the Director, Compliance role at Tonix Pharmaceuticals
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. Commercial launch is expected in the fourth quarter of 2025.
Tonix also markets Zembrace® Sym Touch® and Tosymra® for acute migraine treatment. Tonix's development portfolio includes product candidates in CNS, immunology, infectious disease, rare disease, and more.
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 supports a company wide culture of ethics and compliance and meets or exceeds applicable regulatory standards.
Essential Functions- Assume primary responsibility for all compliance policies and educating business stakeholders; draft, implement, and maintain policies, procedures, work instructions, and training programs.
- Provide strategic direction across all OIG seven elements of an effective compliance program, leveraging industry best practices.
- Manage compliance guidance related to engagements with healthcare professionals, clinical studies, sponsor ships, and grants.
- Lead development and oversight of federal and state transparency reporting programs, including Open Payments (Sunshine Act) and state‑specific disclosure requirements; collaborate cross‑functionally to build scalable systems.
- Design, implement, and oversee a comprehensive compliance monitoring program; lead risk‑based monitoring activities across key business functions; develop insights and drive continuous improvement.
- Develop and deliver effective compliance training programs to employees.
Skills and Abilities
- Maintain current knowledge of laws, regulations, and industry guidance affecting the compliance program, including antikickback, fraud and abuse, bribery, transparency, price reporting, OIG and DOJ guidelines, and PhRMA Code.
- Experience managing compliance programs: drafting policies, implementing training, monitoring initiatives, and investigating sensitive matters.
- Apply a risk‑based analysis to legal and compliance issues and develop solutions that satisfy business and legal requirements.
- Manage and assist in technical solutions for HCP engagement processes.
- Communicate complex compliance concepts effectively to the organization.
- Strong oral, written, and presentation communication skills with superior attention to detail.
- Demonstrate initiative, excellent judgment, proactivity, independent and collaborative work, and relationship building.
- Demonstrated commitment to compliance, ethics, integrity, accountability, and innovation.
- Bachelor's degree at minimum.
- MS or JD degree strongly preferred.
- 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 in an directly applicable law firm.
- Direct compliance experience in the pharmaceutical or medical device industry.
Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition.
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;
Employee Assistance Programs. - Pet Insurance.
- Retirement Savings 401(k) with company match and annual discretionary stock options.
- Generous paid time off, sick time, and 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. Tonix complies with applicable state and local nondiscrimination laws and prohibits workplace harassment based on protected characteristics.
Seniority levelDirector
Employment typeFull‑time
Job functionLegal
IndustriesPharmaceutical Manufacturing
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).