Director, compliance operations - remote us

About Belite Bio

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.

Position Overview

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.

Key Responsibilities

• Transparency Disclosure Reporting and Compliance Systems Oversight
• Hotline Administration and Investigations Support
• Third-Party Compliance Operations
• Reporting, Metrics, and Continuous Improvement

Qualifications & 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.

10-20% travel may be required based on business needs.

Qualifications Education & Experience

Bachelor’s degree required; degree in Business, Life Sciences, Healthcare Administration, Legal Studies, Compliance, Information Systems, or related field preferred. Advanced degree or relevant certifications are 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.

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

Skills & Abilities

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.

Equal Employment Opportunity & Accommodations

Belite Bio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Belite Bio is committed to working with and providing reasonable accommodation to individuals with disabilities. If you need reasonable accommodation for any part of the application or interviewing process due to a medical condition or disability, please contact human resources to let us know the nature of your request.

Salary Disclosure

Pay Range: $223,000 to $240,000 USD (Salary offered will depend on candidate location, market rate adjustments, skills, and relevant experience). Belite Bio provides a competitive total compensation package that includes base salary, annual incentive bonuses, equity participation, and a full benefit package (health, dental, vision, 401(k), and paid time off).