Launch-Ready Head of US Compliance

MoonLake Immunotherapeutics (NASDAQ: MLTX); Miami (FL); Hybrid; USD 210.000 - 320.000; Vollzeit

Zusammenfassung

MoonLake Immunotherapeutics seeks a Senior Director Compliance to design and implement a scalable US compliance program ahead of first commercial activity. The role leads policies, training, and monitoring, embedding risk controls across MoonLake's operations.

Responsibilities include building the policy lifecycle, guiding pre-approval posture, and reporting to executives and the Board on risks and remediation status.

Qualifikationen

• Ten years of progressive healthcare compliance experience in pharma/biotech/medical devices with leadership.
• Expertise in US healthcare laws (AKS, FCA), FCPA, and data protection frameworks.
• Launch-stage program building experience and ability to operate across functions.
• Strong communication, strategic influence, and risk-based decision making.

Aufgaben

• Lead the US compliance program and build a scalable, risk-based framework.
• Finalize policy builds for non-promotional activities, speaker programs and payers.
• Develop Compliance Committee agendas and quarterly board reporting on risk & remediation.
• Maintain policy lifecycle, owners, change log, and cross-reference consistency.
• Own pre-approval posture and launch readiness for regulatory compliance.
• Oversee communications governance for FDA and promotional materials.
• Establish annual enterprise risk assessment and monitoring plans.
• Coordinate Open Payments and state/federal transparency reporting.
• Lead investigations and coordinate with Legal, HR, and external counsel.

Kenntnisse

Regulatory compliance

FDA compliance

OIG guidance

FCPA / anti-corruption

Policy development

Training & monitoring

Risk assessment

Leadership

Cross-functional collaboration

Transparency reporting

Ausbildung

Bachelor's degree in life sciences, business, law, public health, or related field

Advanced degree preferred (e.g., JD, MBA, MPH, PharmD)

CHC or similar Compliance Certification Board credential preferred

Jobbeschreibung

MoonLake Immunotherapeutics seeks a Senior Director Compliance to design and implement a scalable US compliance program ahead of first commercial activity. The role leads policies, training, and monitoring, embedding risk controls across MoonLake's operations.

Responsibilities include building the policy lifecycle, guiding pre-approval posture, and reporting to executives and the Board on risks and remediation status.