Director, Compliance Operations - Remote US

Belite Bio•San Diego, CA

7d•Remote

About The Position

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.

Requirements

Strong knowledge of U.S. laws, regulations, and industry guidance relevant to pharmaceutical compliance programs, including healthcare fraud and abuse laws, federal and state anti-kickback statutes, PhRMA Code, FDA regulations concerning promotional activity, and government agency guidance and enforcement activity.
Demonstrated experience managing and administering key Compliance tools and systems, including Compliance Learning Management Systems, transparency disclosure systems, monitoring and auditing dashboards, risk management platforms, compliance hotline or case management tools, transparency reporting processes, HCP spend reporting processes, third-party compliance platforms, or similar enterprise compliance systems.
Strong understanding of compliance operations, training governance, records management, hotline administration, third-party compliance processes, and audit-ready documentation.
Experience managing Sunshine Act/Open Payments, HCP spend reporting, state transparency requirements, Compliance KPIs, Board reporting packages, and monitoring or auditing report preparation strongly preferred.
Exceptional project management, organizational, analytical, and process-improvement skills, with the ability to manage multiple operational workstreams, deadlines, stakeholders, and system-related priorities.
Excellent communication skills, both oral and written, with the ability to translate compliance requirements into practical operational processes, user guidance, metrics, and reports.
Able to work accurately with an appropriate sense of urgency and function effectively and efficiently in a fast-paced and dynamic environment.
Strong interpersonal skills, including diplomacy, flexibility, collaboration, and the ability to interface effectively across all levels of the organization and with external vendors or partners.
Bachelor’s degree required; degree in Business, Life Sciences, Healthcare Administration, Legal Studies, Compliance, Information Systems, or related field preferred.
Minimum of 10 years of experience in pharmaceutical, biotechnology, healthcare, or life sciences compliance, with significant experience in compliance operations, training operations, policy management, third-party compliance, or compliance systems administration.
Experience administering or serving as business owner for a learning management system or related compliance technology platform required.
Demonstrated ability to build and manage effective relationships within Compliance as well as other key stakeholders, including Legal, Human Resources, Information Technology, Quality, Commercial, Medical, Finance, Procurement, and external vendors.
Strong systems aptitude, including ability to learn, administer, troubleshoot, document, and improve technology-enabled compliance processes.
Exceptional attention to detail and documentation discipline, with the ability to maintain accurate, complete, and inspection-ready records.
Outstanding verbal and written communication skills, with the ability to distill complex compliance and system requirements into clear guidance, procedures, reports, and training materials.
Ability to thrive in a fast-paced, innovative environment with multiple, conflicting priorities and a substantial workload.
Highly self-motivated, proactive, solution-oriented, and able to quickly gain trust and credibility with team members and business stakeholders.
Strong analytical, organizational, reporting, and process-mapping skills.

Nice To Haves

Advanced degree or relevant certifications are preferred.
Experience supporting a growing or pre-commercial organization, product launch environment, or rare disease business preferred.

Responsibilities

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 procedures, job aids, process maps, and administrative controls for Compliance systems.
Use system data and reporting to identify operational risks, process gaps, training needs, and opportunities for continuous improvement, and escalate significant issues to Compliance leadership as appropriate.
Administer the Company’s compliance hotline and reporting channel processes, including vendor coordination, intake workflows, case tracking, documentation, reporting, escalation, and user support in accordance with Company protocols.
Maintain accurate and confidential hotline and case management records, dashboards, metrics, and trend reporting for Compliance leadership review.
Coordinate with Legal, Human Resources, Compliance leadership, and other stakeholders to support timely triage, investigation documentation, remediation tracking, and closure of matters.
Summarize hotline activity, trends, and follow-up items for Compliance leadership and support process improvements based on hotline activity, monitoring results, investigations, and training data.
Coordinate third-party compliance processes, including due diligence documentation, screening support, policy and training assignment, risk-based follow-up, and ongoing monitoring activities.
Work with business owners, Legal, Finance, Procurement, and other stakeholders to help ensure third-party compliance requirements are incorporated into onboarding, contracting, renewal, and oversight processes.
Maintain third-party compliance records, metrics, and reports, including completion status for required diligence, training, certifications, and other compliance obligations.
Recommend and support operational improvements to third-party compliance workflows, controls, documentation, and reporting.
Develop and maintain Compliance Operations dashboards, reports, metrics, and key performance indicators related to disclosure activity, transparency reporting, HCP spend reporting, state transparency obligations, hotline activity, third-party compliance, monitoring outcomes, risk management platform data, and other operational processes.
Prepare metrics, trend analyses, Board reporting packages, monitoring and auditing reports, and Compliance leadership materials for committee updates, audits, governance reviews, and other internal reporting needs.
Coordinate monitoring and auditing report preparation, including findings summaries, remediation tracking, issue escalation, follow-up documentation, and integration of results into compliance dashboards and KPI reporting.
Lead discrete continuous improvement projects to enhance Compliance Operations processes, increase efficiency, strengthen controls, and improve stakeholder experience.
Support Compliance department initiatives beyond primary responsibility as needed to meet organizational objectives and balance workloads.