Senior Director, US Compliance

10+ years of healthcare compliance experience in pharmaceuticals or biotechnology; in-house compliance experience strongly preferred.

In-depth understanding of US healthcare laws and guidance, including the OIG guidelines, PhRMA Code, US Sunshine Law, Anti-Kickback Statute, False Claims Act, FDA promotional regulations, and the FCPA.

Experience as a compliance business partner with familiarity with the compliance risks associated with relevant business activities.

Significant experience supporting pre-commercial pharma or biotech companies through launch planning and commercial product launch.

Demonstrated ability to build strong partnerships and collaborate with internal and external partners at all levels of the organization.

Strategic and pragmatic compliance mindset with strong business acumen.

Director, US Compliance will serve as the lead compliance business partner in support of the company’s planned US commercialization activities for non-small cell lung cancer (NSCLC).

Director will partner with a range of business functions, serve as a trusted resource for compliance guidance, and ensure launch teams successfully navigate the compliance landscape.

This role requires a firm understanding of pharmaceutical best practices and industry requirements, as well as the passion and ability to build relationships with a diverse set of teams all working to revolutionize treatments for patients.

This position will report to the VP, US Compliance.

Director, US Compliance will collaborate and build strong partnerships with several cross-functional stakeholders to help enable commercialization and growth within the NSCLC space.  Areas of focus include:

Serve as the strategic compliance advisor to Commercial, Medical Affairs, Market Access, Patient Services, and other field-facing functions by proactively identifying compliance risks, enabling compliant business solutions, and embedding compliance into key business decisions throughout commercialization and product launch.