Jennifer L. Stevens joined TriSalus in March 2021 and serves as Chief Regulatory Officer. Her responsibilities include leading Regulatory Affairs Strategy and Quality Assurance for both the drug and device components of the business. Jennifer brings us expertise in regulatory affairs, law and policy developed during nearly 30 years of advising clients as a regulatory leader in industry, a regulator at the FDA, and an attorney/partner in several law firms, including Kirkland & Ellis, Willkie, Farr & Gallagher, and Pillsbury, where her work included both compliance counseling and transactional work for clients in regulated industries.
Most recently, Jennifer was Executive Director, Immuno-Oncology/Oncology, Global Regulatory Affairs at EMD Serono (Merck KGaA) where she had oversight responsibility for early and late-stage immuno-oncology/oncology assets. Her accomplishments included regulatory approvals globally for Bavencio, an anti-PD1 therapy being developed in collaboration with Merck KGaA/Pfizer, including BLAs/sBLAs (Merkel Cell carcinoma, 2L urothelial carcinoma (UC), Renal Cell carcinoma, and 1L UC maintenance). Jennifer also conducted due diligence for in-licensing/purchase of early/mid/late stage assets.
Prior to joining the pharma industry, Jennifer spent nearly 5 years as Counsel at the FDA, advising on regulations, policy, and agency guidance.
Jennifer received her bachelor’s degree from the University of Illinois and her JD from George Washington University, graduating cum laude from both institutions.
