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.

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, sponsor ships, 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,…