Director, Compliance

Role Summary

Director, Compliance will play a critical role in the 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. Location: Warren, NJ – 3 days on site & 2 days remote.

Responsibilities

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

Qualifications

• Bachelor’s degree required; Juris Doctor (JD) preferred.
• 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.
• 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.
• Experience managing Compliance programs, including policy development, training implementation, monitoring activities, and investigations.
• Demonstrated ability to think critically, proactively identify Compliance risks, and deliver pragmatic, actionable solutions.
• Strong project management skills with the ability to manage multiple priorities and meet deadlines.
• Proven ability to collaborate effectively with cross-functional and international teams across multiple time zones.
• Excellent written, verbal, and presentation skills, with the ability to translate complex Compliance topics for diverse audiences.
• Strong commitment to ethics, integrity, accountability, and a culture of Compliance and innovation.

Skills

• Curiosity: Always ask why and why not; explore uncharted territories.
• Courage: Take smart risks, mentor others, and be accountable for choices and actions.
• Collaboration: Teamwork and active involvement in achieving common goals.
• Credibility: Be transparent, follow through, and build trust through understanding the technology.

Education

• Bachelor’s degree required; Juris Doctor (JD) preferred.