Director, Compliance Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and enhance the operational framework that supports Belite Bio’s Compliance Program.

• Administer and optimize systems for transparency disclosure, monitoring and auditing dashboards, risk management platforms, policy and training systems, and hotline administration procedures.

• Oversee transparency reporting, HCP spend reporting, state transparency requirements related to marketing and pricing, compliance hotline management, third-party compliance operational support, policy and training oversight, as well as auditing and monitoring metrics.

• Direct State and Federal Sunshine Act/Open Payments readiness, including HCP spend data collection, data quality assessments, correction workflows, documentation, submissions, and coordination with stakeholders, vendors, and third parties.

• Monitor and coordinate state transparency requirements, reporting timelines, submissions, recordkeeping, and escalation of compliance issues.

• Manage daily administration and support of compliance systems and tools, covering user access, configuration support, data integrity, reporting, documentation, and vendor engagement.

• Collaborate with Information Technology and system vendors on enhancements, issue resolution, testing, validation support, change management, and business continuity.

• Supervise annual and event-based disclosures, conflict-of-interest tracking, certifications, follow-up workflows, reporting, and risk escalation.

• Create and maintain monitoring and auditing dashboards, risk management reporting, standard operating procedures, job aids, process maps, and administrative controls.

• Identify operational risks, process deficiencies, training requirements, and opportunities for continuous improvement using system data and reporting.

• Oversee the compliance hotline and reporting channels, including vendor coordination, intake workflows, case tracking, documentation, reporting, escalation, and user support.

• Safeguard confidential hotline and case management records, dashboards, metrics, and trend reporting.

• Coordinate with Legal, Human Resources, Compliance leadership, and other stakeholders on triage, investigation documentation, remediation tracking, and matter closure.

• Summarize hotline activity, trends, and follow-up items for Compliance leadership.

• Oversee third-party compliance processes, which include due diligence documentation, screening support, policy and training assignments, risk-based follow-up, and ongoing monitoring.

• Collaborate with business owners, Legal, Finance, Procurement, and other stakeholders to integrate third-party compliance requirements into onboarding, contracting, renewal, and oversight.

• Maintain records, metrics, and reports related to third-party compliance.

• Develop dashboards, reports, metrics, and KPIs for disclosure activities, transparency reporting, HCP spend reporting, state transparency obligations, hotline activity, third-party compliance, monitoring outcomes, and risk management data.

• Prepare metrics, trend analyses, Board reporting packages, monitoring and auditing reports, and materials for Compliance leadership.

• Coordinate the preparation of monitoring and auditing reports, findings summaries, remediation tracking, issue escalation, and follow-up documentation.

• Lead continuous improvement initiatives to refine processes, bolster controls, and enhance stakeholder experience.

• Report directly to the Chief Compliance Officer.

⛳️ Requirements

• Thorough understanding of U.S. laws, regulations, and industry guidelines relevant to pharmaceutical compliance programs, including healthcare fraud and abuse laws, federal and state anti-kickback statutes, PhRMA Code, FDA regulations regarding promotional activities, and government agency guidance and enforcement actions.

• Proven experience in managing and administering 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 grasp of compliance operations, training governance, records management, hotline administration, third-party compliance processes, and audit-ready documentation.

• Experience with Sunshine Act/Open Payments, HCP spend reporting, state transparency requirements, Compliance KPIs, Board reporting packages, and preparation of monitoring or auditing reports is highly preferred.

• Exceptional project management, organizational, analytical, and process improvement skills.

• Excellent verbal and written communication abilities.

• Capacity to work accurately with a sense of urgency in a fast-paced and dynamic setting.

• Strong interpersonal skills, including diplomacy, adaptability, collaboration, and effective interaction across all organizational levels and with external vendors or partners.

• Willingness to travel 10–20% based on business needs.

• Bachelor’s degree is required.

• At least 10 years of experience in pharmaceutical, biotechnology, healthcare, or life sciences compliance, with significant expertise in compliance operations, training operations, policy management, third-party compliance, or compliance systems administration.

• Experience in administering or serving as a business owner for a learning management system or related compliance technology platform is required.

• Experience in supporting a growing or pre-commercial organization, product launch environment, or rare disease business is preferred.

• Ability to cultivate and manage effective relationships with Compliance and stakeholders including Legal, Human Resources, Information Technology, Quality, Commercial, Medical, Finance, Procurement, and external vendors.

• Strong aptitude for systems, including the ability to learn, administer, troubleshoot, document, and enhance technology-enabled compliance processes.

• Exceptional attention to detail and discipline in documentation.

• Outstanding verbal and written communication skills, including the ability to translate complex compliance and system requirements into clear guidance, procedures, reports, and training materials.

• Capability to thrive amid multiple conflicting priorities and a substantial workload.

• Highly self-motivated, proactive, solution-oriented, and capable of earning trust and credibility with stakeholders.

• Strong analytical, organizational, reporting, and process mapping skills.

• Authorization to work in the United States is required.

🏝️ Benefits

• Annual incentive bonuses.

• Equity participation.

• Health insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• Paid time off.

• Reasonable accommodation for individuals with disabilities.