Associate Director, Compliance

Abeona Therapeutics Inc. (ABEO) is a clinical-stage biopharmaceutical company developing cell & gene therapies for serious and life-threatening diseases.

RDEB is a rare, inherited connective tissue disease in which both copies of collagen-producing genes (Col7A1) are mutated. In the absence of collagen protein, skin becomes fragile and even the slightest shear can result in severe blistering and formation of wounds that are often painful, large, and chronic. Patients live a debilitating life often wrapped in bandages to minimize the risk of infections, carcinomas, and an untimely death. Pz-cel is a breakthrough therapy that has demonstrated remarkable results in pivotal Phase 3 studies. Based on the high unmet need, strong clinical profile of EB-101, and the significant commercial opportunity, Abeona has decided to build a nimble commercial organization to launch pz-cel following its potential approval in the U.S. next year.

Abeona is seeking an Associate Director, Compliance who will assist in directing and coordinating the compliance activities of the Company as it moves toward commercialization of this complex autologous cell therapy product. The AD, Compliance will be a member of the Legal team and, with the General Counsel, will be responsible for ensuring that the company complies with all applicable laws and regulations, as well as developing and implementing policies and procedures to prevent and detect misconduct.

In addition, the AD, Compliance will assist Senior Corporate Counsel with other Legal team activities, including triaging, drafting and negotiating company contracts.

Key Responsibilities:

• Provide compliance guidance on promotional and non-promotional materials to minimize company risk and facilitate compliance that is in alignment with applicable regulations.
• Create and implement Company policies and SOPs relating to laws and regulations impacting commercial drug products, including the Anti-Kickback Statute, Physician Self-Referral (Stark) Law, False Claims Act, and other applicable federal, state, and industry rules and guidelines
• Provide guidance on patient advocacy and patient-centered engagement matters
• Periodically review and recommend revisions to the Company’s Code of Conduct, Compliance Program, Privacy Policy, and compliance policies and procedures to ensure that they properly address current risk areas and are up to date
• Monitor, investigate and respond to reports of unlawful and unethical conduct received via the Company’s Compliance Hotline or as otherwise reported to the Legal Department; work with outside counsel when necessary
• Develop corrective action plans to address identified unlawful and unethical conduct
• Collaborate cross-functionally across Abeona
• Monitor and maintain knowledge of the evolving regulatory landscape to provide relevant solutions and advice
• Act as a representative on select cross functional teams or Committees as assigned for matters relating to Commercial Compliance including task forces
• As directed by the General Counsel and Senior Corporate counsel, triage, draft and negotiate company contracts
  
  

Qualifications:

• Juris Doctor from an accredited law school
• Admission to and maintenance of good standing with a State Bar
• 5 years of legal work experience, including 2 years in-house within the biotech or pharmaceutical industry
• Knowledge of pharma industry compliance activities, regulatory landscape, pharmaceutical compliance training and monitoring programs
• Experience with creating and delivering effective compliance training
• Experience in small or mid-sized companies, with do-er/leader mentality
• Experience working from pre-launch through commercialization strongly preferred
• Individual integrity and uncompromising ethical principles, particularly as it relates to the attorney-client relationship and compliance with laws and regulations
• Experience drafting and reviewing commercial contracts, consulting agreements, NDAs, and the like
• Leadership courage and strong influencing skills to facilitate cross-functional interactions
• Ability to work both independently and as part of a team
• Excellent verbal and written communication skills with an ability to communicate complex legal and compliance matters to non-lawyers
• Strong analytical and problem-solving skills and attention to detail, with an ability to work independently
  
  

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