U.S. Compliance Director — Biopharma Launch Readiness

Henlius USA Inc.; New Jersey; On-site; USD 180,000 - 280,000; Full time

Job summary

Henlius USA Inc. is seeking an experienced Director, U.S. Compliance to establish and lead the U.S. compliance program as the first dedicated U.S.

compliance leader. You will develop 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 role will partner with Global Compliance, China HQ Legal and business teams, and U.S.

Qualifications

• 8+ years of U.S. healthcare or commercial compliance experience in pharma/biopharma.
• Experience supporting a U.S. commercial launch or pre-launch company.
• Strong knowledge of AKS, False Claims Act, FDA promo rules and related guidance.
• Experience developing policies, SOPs, controls, training, and investigations.
• Experience advising on HCP engagements, speaker programs, and third-party arrangements.
• Open Payments, state reporting, and value-based arrangements experience preferred.

Responsibilities

• Lead the U.S. Compliance Program: build, implement, and continuously improve a risk-based program.
• Serve as U.S. Compliance SME: advise on regulatory and operational requirements for U.S. activities.
• Manage risk assessments and regulatory intelligence: annual plan and enforcement trends.
• Enable compliant launch and operations: establish controls for engagements, events, grants, contracts.
• Advise on commercial and market access activities: input for promotions, payer engagements, pricing.
• Oversee transparency and third-party data compliance; lead investigations and remediation when needed.
• Build culture and capability: deliver training and align global governance with U.S. needs.

Skills

US healthcare compliance

Anti-Kickback Statute

False Claims Act

HHS-OIG guidance

Open Payments & transparency

Regulatory risk assessment

Job description

Henlius USA Inc. is seeking an experienced Director, U.S. Compliance to establish and lead the U.S. compliance program as the first dedicated U.S.

compliance leader. You will develop 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 role will partner with Global Compliance, China HQ Legal and business teams, and U.S.