Director, Compliance

Role Summary

Director, Compliance will lead development, implementation, and ongoing management of DBV’s global Compliance Program, serving as a strategic compliance business partner to key internal stakeholders across the organization. The role focuses on aligning with regulatory requirements, developing policies and training, and overseeing risk-based monitoring and investigations to support clinical studies, sponsorships, grants, and other regulated activities. Location: Warren, NJ (3 days on site, 2 remote).

Responsibilities

• Act as a primary Compliance business partner to key functions, including Commercial and Medical Affairs.
• Provide strategic support to design, implement, and continuously improve an effective Compliance program aligned with regulatory requirements and industry best practices.
• Develop, maintain, and implement Compliance policies, procedures, and training programs to promote ethical conduct and regulatory awareness.
• Oversee Compliance guidance related to interactions with healthcare professionals (HCPs), including fair market value assessments, HCP tiering, and review of proposed engagements.
• Manage Compliance frameworks for clinical studies, sponsorships, grants, and other regulated activities.
• Lead transparency and disclosure programs (e.g., Open Payments / Sunshine Act and state-specific requirements), ensuring accurate and timely reporting through cross-functional collaboration.
• Design and execute risk-based monitoring and auditing activities, including field monitoring, speaker program observations, advisory boards, and third-party due diligence.
• Monitor evolving legal and regulatory requirements and assess their impact on the Compliance program.
• Support investigations of potential Compliance violations and contribute to remediation and continuous improvement initiatives.

Qualifications

• Required: Bachelor’s degree.
• Preferred: Juris Doctor (JD).
• Required: Minimum 8+ years of U.S. healthcare compliance experience within a biotech or pharmaceutical environment; alternatively, a JD with 5+ years of relevant compliance experience.
• Required: Solid understanding of U.S. healthcare laws and regulations applicable to the biotech and pharmaceutical industry, including the False Claims Act, Anti-Kickback Statute, federal and state transparency laws, OIG and DOJ guidance, and the PhRMA Code.
• Required: Experience managing Compliance programs, including policy development, training implementation, monitoring activities, and investigations.
• Required: Demonstrated ability to think critically, proactively identify Compliance risks, and deliver pragmatic, actionable solutions.
• Required: Strong project management skills with the ability to manage multiple priorities and meet deadlines.
• Required: Proven ability to collaborate effectively with cross-functional and international teams across multiple time zones.
• Required: Excellent written, verbal, and presentation skills, with the ability to translate complex Compliance topics for diverse audiences.
• Required: Strong commitment to ethics, integrity, accountability, and a culture of Compliance and innovation.

Skills

• Curiosity: Ask why and why not to push boundaries in compliance.
• Courage: Take smart risks, mentor others, and be accountable for choices and actions.
• Collaboration: Team-oriented, supportive, and engaged in achieving shared goals.
• Credibility: Build trust through transparency, follow-through, and understanding of the technology.