Enabling patients with autoimmune diseases to reimagine life. Backed by NEA and Norwest.
About the role
Zenas BioPharma is looking for a Director of Global Compliance to play a central role in shaping and advancing our global ethics and compliance program as we move toward commercial launch. This is a high-impact, highly visible role that sits at the intersection of compliance, business partnership, and organizational culture.
What they're looking for
- Bachelor's degree required
- 5–8 years of progressive healthcare compliance experience within a pharmaceutical, biotechnology, or medical device organization
- Experience supporting first commercial launch preferredSolid understanding of the elements of an effective compliance program, including DOJ and HHS OIG guidance
- Deep knowledge of US healthcare fraud and abuse laws (Anti-Kickback Statute, False Claims Act), transparency laws and regulations (Sunshine Act), and the PhRMA Code on Interactions with Healthcare Professionals
- Familiarity with anti-bribery and anti-corruption legislation, including the Foreign Corrupt Practices Act (FCPA) and similar global regulations
- Experience with healthcare compliance systems, HCP engagement, transparency reporting, and third-party risk management
More about this role
Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase...
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