Sr Counsel, Commercial Legal and 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 Sr Counsel, Commercial Legal and Compliance is a key liaison for a broad range of commercial and compliance related items across the company as we continue to launch our most recently approved drug product. This position works with members of the Legal and Compliance team, members of the Commercial, Medical Affairs and Regulatory Affairs teams, and cross-functionally across the company as the brand attorney supporting the launch and commercialization of the company’s recently approved fibromyalgia product. This role also supports the company’s established products. Additionally, this role supports the continued design, development, implementation, and management of the company’s healthcare and other compliance programs.

Essential Functions

• Serves as the brand attorney/product lawyer supporting the launch and commercialization of the company’s new and established commercial prescription drug products, including advising on advertising and promotion, sales and marketing initiatives, medical affairs initiatives, compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals, payors, patients, and patient advocacy organizations.
• In partnership with the Head of Commercial Legal and Compliance, the General Counsel EVP, Operations and other members of the Legal and Compliance team, develops, implements and maintains the company’s healthcare, corporate, and other compliance policies, procedures and practices.
• Participates and provides counsel on Medical, Legal and Regulatory (MLR) Review committees for promotional and non-promotional communications and materials.
• Develops, oversees and, where needed, leads compliance training to company personnel.
• Conducts compliance investigations and remediates compliance matters.
• Maintains a current working knowledge of and provide advice regarding various laws, regulations, and industry guidance that affect the commercialization of prescription drugs, including antikickback and fraud and abuse laws, transparency laws, state drug pricing transparency laws, OIG and DOJ guidelines, FDA, FTC and competition law, and industry standards.
• Advise on other legal issues, including privacy, market access and U.S. patient support program initiatives.

Necessary Skills and Abilities

• Experience with promotional /non-promotional review and with compliance matters relating to the launch and commercialization of pharmaceutical products.
• Comprehensive knowledge of laws regarding kickbacks, fraud and abuse, false claims, drug development and marketing, price reporting, government contracting, transparency, bribery and corruption.
• Experience managing compliance programs, including drafting policies, implementing training standards, 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.
• 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, and innovation accountability.
• Supervising and directing outside counsel effectively.

Requirements

• Juris Doctorate Degree.
• 9 years of relevant brand/product and healthcare compliance experience, including at least 4 years of experience in the pharmaceutical industry; prior industry and government experience preferred.
• Prescription drug product launch experience preferred.