Director US Compliance, BioPharma

Henlius is a global, innovation-driven, patient-centric biopharmaceutical company committed to delivering high-quality, affordable biologic therapies worldwide. As we expand in the United States and prepare for our first commercial launch in 2027, we are seeking an experienced, proactive, business-minded **Director, U.S. Compliance** to establish and lead our U.S. compliance program. As Henlius’s first dedicated U.S. compliance leader, this role will serve as the primary subject matter expert on U.S. healthcare compliance. The Director will develop and implement a practical, risk-based framework supporting U.S. clinical, pre-commercial, commercial, medical, market access, patient support, and corporate activities. Reporting to the China-based Head of Compliance, the Director will partner with Global Compliance, China HQ Legal and business teams, and U.S. leadership. The role will provide U.S. compliance guidance for global policies, risk assessments, investigations, training, third-party oversight, and governance; identify and elevate material risks; and recommend practical solutions tailored to the U.S. business environment. As Henlius grows, this role may expand to include building and leading a dedicated U.S. compliance team. Key Responsibilities Lead the U.S. Compliance Program : Build, implement, and continuously improve a risk-based program, including policies, SOPs, governance, reporting, documentation, metrics, escalation pathways, and operating model. Report material risks, monitoring results, investigations, and remediation to U.S. and global leadership. Serve as U.S. Compliance SME : Advise U.S. operations and Global Compliance on applicable legal, regulatory, and operational requirements. Partner with Clinical Development, Quality, Regulatory, Pharmacovigilance, and Medical Affairs on U.S.-specific matters, including investigator and research-related HCP engagements. Manage Risk Assessment and Regulatory Intelligence : Conduct periodic risk assessments, develop and execute the annual compliance plan, and monitor relevant federal and state laws, enforcement trends, regulations, and industry guidance. Enable Compliant Launch and Operations : Support cross-functional launch and business teams. Establish controls for HCP/HCO engagements, speaker programs, advisory boards, consulting arrangements, field activities, congresses, meals, travel, FMV, contracts, approvals, documentation, aggregate spend, and monitoring. Oversee controls for grants, charitable contributions, sponsorships, independent medical education, and patient-advocacy organizations. Advise on Commercial and Market Access Activities : Provide compliance input for MLR review, promotional and non-promotional activities, Medical Affairs, payer and customer engagements, patient-support and distribution programs, pricing, and contracting. Partner with Market Access, Finance, and Legal on government programs, rebates, discounts, price reporting, Medicaid Drug Rebate Program, 340B, drug-price transparency, and value-based arrangements. Oversee Transparency, Third-Party, and Data Compliance : Establish processes for Open Payments, state transparency and aggregate-spend reporting, gift bans, sales-representative registration, and drug-price transparency. Implement risk-based due diligence, contracting, training, and monitoring for vendors and other third parties. Partner with Privacy, IT, Legal, and Global Compliance on U.S. privacy and cross-border data issues. Lead Monitoring, Investigations, and Remediation : Conduct risk-based monitoring and auditing across field activities, expenses, HCP engagements, speaker programs, transactions, and third parties. Coordinate intake, triage, investigations, documentation, corrective actions, and remediation with Legal, HR, and Global Compliance. Build Culture and Capability : Deliver role-based training and communications that promote integrity, accountability, and non-retaliation. Align global governance with U.S. requirements, assess resource and technology needs, manage external providers, and build a U.S. compliance team as the organization grows. Requirements 8+ years of progressive U.S. healthcare or commercial compliance experience in the pharmaceutical or biopharmaceutical industry. Experience supporting a U.S. commercial launch or late-stage pre-launch organization; experience building compliance infrastructure in a pre-commercial or newly commercial company strongly preferred. Strong knowledge of the Anti-Kickback Statute, False Claims Act, FDA promotional requirements, HHS-OIG guidance, PhRMA Code, federal and state transparency requirements, state gift/marketing restrictions, and related healthcare fraud-and-abuse principles. Demonstrated experience developing compliance policies, SOPs, controls, training, risk assessments, monitoring/auditing activities, investigations, and remediation plans. Experience advising on HCP engagements, speaker programs, advisory boards, medical education, grants, patient-support programs, and third-party arrangements. Experience with Open Payments and state aggregate-spend reporting; government pricing, market access, and patient-support compliance experience strongly preferred. Sound judgment and the ability to provide timely, practical, well-documented, risk-based advice in a fast-paced environment. Ability to influence senior stakeholders and collaborate across Commercial, Medical Affairs, Market Access, Legal, Regulatory, Finance, U.S., and global/HQ teams. Preferred Qualifications Experience serving as the primary compliance lead for a biopharma company’s first U.S. commercial launch or transition from pipeline to commercial-stage operations. Experience implementing and managing compliance technology and service providers, including MLR/content review, HCP engagement/FMV, aggregate spend/Open Payments, monitoring, and investigation tools. Demonstrated leadership potential, including resource planning, budget or provider management, and mentoring staff or contractors. Experience supporting compliance committees and presenting risks, audit findings, and remediation plans to executive leadership, a Board, or an Audit Committee. Experience with hotline programs, compliance investigations, and corrective-action processes. Experience in oncology, biologics, biosimilars, specialty products, or provider-administered therapies. Experience working with an international parent company and cross-border governance or data-transfer requirements; China/Asia experience preferred. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 10 products have been approved for marketing worldwide, and 5 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation center and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos® and Bilprevda®. and pertuzumab Poherdy®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. For more information, please visit #J-18808-Ljbffr Henlius USA Inc.