Director, Compliance Operations - Remote

Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases with significant unmet medical needs. Built on our proprietary Retinol Binding Protein 4 (RBP4) IP portfolio, our clinical pipeline includes Tinlarebant (LBS-008), an oral therapy currently in late-stage clinical trials (including the Phase 3 DRAGON and PHOENIX studies) for Stargardt disease (STGD1) and Geographic Atrophy (GA) in dry AMD.

At Belite Bio, we are dedicated to developing innovative solutions to treat untreatable conditions and prevent vision loss in patients worldwide. As an early-stage company, we value entrepreneurial thinking, collaboration, accountability and the ability to thrive in fast moving environments.

The Director of Compliance Operations is a member of the Compliance team responsible for leading and improving the operational infrastructure that supports Belite Bio’s Compliance Program. Reporting to the Chief Compliance Officer, this role will have primary responsibility for administering and optimizing the Company’s compliance operations systems, including the transparency disclosure systems, monitoring and auditing dashboards, risk management platforms, policy and training platforms, and hotline administration processes that enable effective, timely, and auditable compliance activity across the organization.

This position will lead key compliance operations activities, including compliance systems support, transparency reporting and HCP spend reporting, state transparency requirements related to marketing and pricing, compliance hotline administration, third-party compliance operational support, policy and training management, and auditing and monitoring metrics. The role requires strong project management, attention to detail, systems aptitude, cross-functional coordination, and practical compliance judgment to ensure that operational processes are efficient, well-controlled, and aligned with applicable laws, regulations, industry standards, and Company policies.

• Lead Company’s compliance with transparency reporting requirements, including State and Federal Sunshine Act/Open Payments readiness, HCP spend data collection, data quality review, correction workflows, documentation, submissions, and coordination with internal stakeholders and external reporting vendors and third parties.
• Track and coordinate state transparency requirements related to pharmaceutical marketing and pricing, including reporting calendars, submission support, recordkeeping, and escalation of potential compliance gaps.
• Manage day-to-day administration and support of Compliance systems and tools, including the disclosure systems, policy and training management systems, monitoring and auditing dashboards, and risk management platforms with responsibility for user access, system configuration support, data quality, reporting, documentation, and vendor coordination.
• Work with Information Technology and system vendors to support enhancements, issue resolution, testing, validation support, change management, and business continuity for Compliance operational systems.
• Oversee disclosure system processes, including annual and event-based disclosures, conflict-of-interest tracking, certifications, follow-up workflows, reporting, and escalation of potential risk areas to Compliance leadership.
• Develop and maintain monitoring and auditing dashboards and risk management platform reporting to track compliance risks, control activities, remediation status, trends, and operational performance indicators.
• Develop and maintain standard operating…