Director, Compliance

Tonix Pharmaceuticals•Berkeley Heights, NJ

1d•$180,000 - $210,000

About The Position

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. 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.

Requirements

Bachelor’s degree
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

Nice To Haves

MS, JD, MBA or other relevant advanced degree strongly preferred

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