Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. We are seeking a Vice President, Healthcare Law, reporting to the Deputy General Counsel, to join our RevMed team. The Vice President, Healthcare Law will provide strategic legal guidance related to the company’s planned commercialization activities, including related to market access, patient access programs, distribution and licensing, and regulatory submissions. A successful candidate will bring proven experience working at a publicly traded life sciences organization, with demonstrated success in driving legal cross-functional strategy. Serve as a legal advisor to members of the executive team on a wide range of commercialization issues with broad enterprise impact. Serve as legal representative for Commercialization and Medical-related committees and teams, including promotional review, medical materials, and educational and charitable grants. Serve as the lead counsel for healthcare regulatory law, including the FDCA and related Regulations, and Guidance Documents, fraud and abuse laws and guidances (Anti-Kickback Statute, False Claims Act, OIG Guidance and Advisory Opinions), and federal and state transparency and reporting laws. Provide legal counsel on regulatory interactions with FDA and other regulatory authorities. Coordinate with Compliance sub-function to operationalize compliance in commercialization activities, including related to promotional materials, scientific exchange, and interactions with HCPs. Provide strategic legal advice related to patient support programs, patient hubs, market access, pricing, reimbursement, and distribution via different channels and interest groups (e.g., specialty distributors, specialty pharmacies, PBMs, GPOs, 340B hospitals) and oversee commercial contracting. Advise on issues regarding clinical trials, including related to CT.gov compliance, data privacy, interactions with clinical sites and investigators, CTA contracting and ICFs. Proactively monitor emerging healthcare and regulatory law trends, such as Biosecure, IRA, and MFN pricing, and assess and communicate their impact on RevMed. Build and manage teams in a dynamic high-growth environment.
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Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree