Launch-Ready Compliance Director (Hybrid/Remote)

MoonLake Immunotherapeutics; Miami (FL); Hybrid; USD 210,000 - 320,000; Full time

Job summary

MoonLake Immunotherapeutics seeks a Senior Director to design and implement a scalable US compliance program from the ground up. You will own governance, policy development, and training across US operations while coordinating with European and Swiss activities as needed.

You will lead risk assessments, policy lifecycle management, and monitoring for launch readiness, pre-approval communications, and aggregate spend reporting, ensuring governance and integrity across the organization.

Qualifications

• Bachelor's degree required in life sciences, business, law, public health, or related field.
• Advanced degree such as JD, MBA, MPH, or PharmD preferred.
• CHC or CCB compliance certification preferred.

Responsibilities

• Lead implementation and continuous improvement of the US compliance program, including Code of Conduct and policy suite.
• Own pre-approval posture and launch readiness for pre-launch activities.
• Oversee anti‑kickback, False Claims Act, and other regulatory compliance across US and international activities.
• Develop agendas for Compliance Committee and deliver quarterly reporting to leadership and Board.
• Establish policy lifecycle with version control, review cadence, and cross-references.

Skills

Regulatory compliance

Leadership

Policy development

Training & education

Risk assessment

Education

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

Advanced degree preferred (JD, MBA, MPH, PharmD)

Job description

MoonLake Immunotherapeutics seeks a Senior Director to design and implement a scalable US compliance program from the ground up. You will own governance, policy development, and training across US operations while coordinating with European and Swiss activities as needed.

You will lead risk assessments, policy lifecycle management, and monitoring for launch readiness, pre-approval communications, and aggregate spend reporting, ensuring governance and integrity across the organization.