Director, Compliance Operations

Vaga não está no LinkedIn

🕒 Outubro 30

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $223.000 - $240.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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Belite Bio

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2018

🧬 Biotecnologia

💊 Farmacêutico

🔥 Investimento no último ano

💰 $402.000.000 Post-IPO Equity em 2025-12

Biotechnology • Pharmaceuticals

A Belite Bio é uma empresa biofarmacêutica em estágio clínico que desenvolve terapias inovadoras com base em seu portfólio de propriedade intelectual relacionado à RBP4 (Retinol Binding Protein 4). Seu principal candidato, o tinlarebant (LBS-008), é uma terapia oral desenvolvida para reduzir o acúmulo de substâncias tóxicas nos olhos e está sendo desenvolvido para doenças degenerativas da retina, incluindo a doença de Stargardt autossômica recessiva (STGD1) e a atrofia geográfica (degeneração macular relacionada à idade do tipo seca em estágio avançado). A Belite Bio está conduzindo múltiplos estudos clínicos — incluindo programas de Fase 1b/2, Fase 2/3 e Fase 3, como DRAGON, DRAGON II e PHOENIX — e o tinlarebant recebeu diversas designações regulatórias (Orphan Drug nos EUA, na União Europeia e no Japão; Rare Pediatric Disease; Breakthrough Therapy; Fast Track; e Sakigake). O pipeline da empresa também inclui programas voltados ao tratamento de doenças metabólicas e hepáticas, como a doença hepática gordurosa não alcoólica e o diabetes tipo 2.

Descrição

• Lead and improve the operational infrastructure supporting Belite Bio’s Compliance Program • Administer and optimize transparency disclosure systems, monitoring and auditing dashboards, risk management platforms, policy and training platforms, and hotline administration processes • Lead transparency reporting, 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 • Lead State and Federal Sunshine Act/Open Payments readiness, HCP spend data collection, data quality review, correction workflows, documentation, submissions, and coordination with stakeholders, vendors, and third parties • Track and coordinate state transparency requirements, reporting calendars, submissions, recordkeeping, and escalation of compliance gaps • Manage day-to-day administration and support of Compliance systems and tools, including user access, configuration support, data quality, reporting, documentation, and vendor coordination • Work with Information Technology and system vendors on enhancements, issue resolution, testing, validation support, change management, and business continuity • Oversee annual and event-based disclosures, conflict-of-interest tracking, certifications, follow-up workflows, reporting, and risk escalation • Develop and maintain monitoring and auditing dashboards, risk management reporting, standard operating procedures, job aids, process maps, and administrative controls • Identify operational risks, process gaps, training needs, and continuous improvement opportunities using system data and reporting • Administer the compliance hotline and reporting channels, including vendor coordination, intake workflows, case tracking, documentation, reporting, escalation, and user support • Maintain 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 • Coordinate third-party compliance processes, including due diligence documentation, screening support, policy and training assignment, risk-based follow-up, and ongoing monitoring • Work with business owners, Legal, Finance, Procurement, and other stakeholders to incorporate third-party compliance requirements into onboarding, contracting, renewal, and oversight • Maintain third-party compliance records, metrics, and reports • Develop dashboards, reports, metrics, and KPIs for disclosure activity, 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 Compliance leadership materials • Coordinate monitoring and auditing report preparation, findings summaries, remediation tracking, issue escalation, and follow-up documentation • Lead continuous improvement projects to enhance processes, strengthen controls, and improve stakeholder experience • Report to the Chief Compliance Officer

🎯 Requisitos

• 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 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 • Excellent oral and written communication skills • Ability to work accurately with an appropriate sense of urgency in a fast-paced and dynamic environment • Strong interpersonal skills, including diplomacy, flexibility, collaboration, and effective interaction across all organizational levels and with external vendors or partners • 10–20% travel may be required based on business needs • Bachelor’s degree required • 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 • Ability to build and manage effective relationships with Compliance and 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 • Outstanding verbal and written communication skills, including translating complex compliance and system requirements into clear guidance, procedures, reports, and training materials • Ability to thrive with multiple conflicting priorities and a substantial workload • Highly self-motivated, proactive, solution-oriented, and able to gain trust and credibility with stakeholders • Strong analytical, organizational, reporting, and process-mapping skills • Authorization to work in the United States

🏖️ Benefícios

• Annual incentive bonuses • Equity participation • Health insurance • Dental insurance • Vision insurance • 401(k) • Paid time off • Reasonable accommodation for individuals with disabilities

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