Senior Director Compliance

Job Purpose

The Senior Director Compliance will serve as MoonLake's senior internal compliance leader and the day-to-day owner of the United States compliance program. This is a build role rather than a maintenance role. MoonLake has no approved product currently on the market, and the successful candidate will be designing and implementing a scalable, risk-based compliance framework, policies, processes, forms, tools, training, monitoring, and transparency reporting, and embedding them in a lean and fast-moving organization before the first commercial interaction occurs.
The role will lead and operationalize MoonLake´s compliance framework across its United States operations and, where relevant, its European and Swiss activities. Key areas of responsibility include US healthcare fraud and abuse laws, including the Federal Anti-Kickback Statute and the False Claims Act; the Federal Food, Drug, and Cosmetic Act and FDA advertising and promotion requirements, including the restrictions that apply to a company with no approved product; federal and state transparency and aggregate spend reporting; federal exclusion and debarment screening; the United States Foreign Corrupt Practices Act; the EFPIA Disclosure Code and applicable national codes to the extent MoonLake's activities have European reach; the revised Swiss Federal Act on Data Protection and the EU General Data Protection Regulation as they apply to MoonLake's operations. In addition, the role