Associate Director, Healthcare Law

About this role

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor-all in service of patients. The Opportunity: We are seeking an Associate Director, Healthcare Law (Brand Counsel) to join our RevMed Legal team as we prepare for multiple upcoming indication expansions and launches of daraxonrasib, our multi-selective RAS(ON) inhibitor. Reporting to the Senior Director, Healthcare Law, who oversees the daraxonrasib portfolio, the AD will serve as lead brand counsel for an assigned daraxonrasib indication and therapeutic area, owning legal support from launch readiness through commercialization. The AD will provide strategic, business-oriented legal guidance to the cross-functional team for that indication, including promotional and non-promotional material review through the Promotional Review Committee (PRC) and Medical Review Committee (MRC), commonly known as MLR review. A successful candidate will bring experience at a publicly traded life sciences company or a reputable FDA regulatory/life sciences law firm practice, with a demonstrated ability to drive cross-functional legal strategy and support product launches. Responsibilities: Serve as lead brand counsel and key legal business partner for an assigned daraxonrasib indication, partnering with Commercial, Medical Affairs, Regulatory, Compliance, and other functions to provide practical, risk-calibrated advice on commercialization matters. Lead legal launch readiness for the assigned indication, including pre-approval communications, development of core claims and launch materials, review of launch campaigns, and coordination with Regulatory on labeling and approval timelines. Serve as legal reviewer on PRC and MRC, reviewing promotional materials-including HCP and consumer/DTC, digital, social media, sales training, speaker program, and congress/exhibit materials-and non-promotional/medical scientific exchange materials for compliance with the FDCA, FDA regulations and guidance, and Company policy. Advise on the line between promotion and scientific exchange, including off-label communications, medical information responses, MSL activities, publications, advisory boards, and pre-approval and payor communications, including PIE/HCEI under FDORA and the 21st Century Cures Act. Advise on the FDCA and related FDA regulations and guidance; fraud and abuse laws, including the Anti-Kickback Statute (AKS), False Claims Act (FCA), Civil Monetary Penalties Law, and related OIG guidance; and federal and state transparency requirements, including the Sunshine Act/Open Payments and state marketing and price transparency laws. Coordinate with Compliance to operationalize compliance in commercial activities, including policies, SOPs, training, HCP interactions, speaker programs, and fair market value processes. Provide strategic legal advice on patient support programs, hub services, copay and patient assistance programs, independent charitable foundations, and market access and payor materials. Develop and deliver training to brand, commercial, and medical teams on advertising and promotion and healthcare compliance topics; contribute to process improvements for review committees. Participate with other members of the Healthcare Law Team in monitoring and assessing emerging healthcare, drug pricing, supply chain, sate law, and FDA enforcement developments (including OPDP untitled and warning letters), and communicate their potential impact on RevMed. Manage outside counsel on select healthcare law and commercialization matters. Role Evolution This description reflects the general nature and level of the role and is not an exhaustive list of duties. Responsibilities may evolve with business needs, and the AD will be expected to support additional Legal team priorities as they arise. RevMed is committed to the AD's professional development and growth, and as the daraxonrasib portfolio and the Legal team expand, the role will offer opportunities to broaden its scope and responsibilities, including leadership and professional development. Required Skills, Experience and Education: Juris Doctor (JD) degree from an accredited law school. Active bar membership in good standing in at least one U.S. jurisdiction; if based in California, California bar membership or eligibility to register as Registered In-House Counsel. 8+ years of relevant legal experience, including meaningful experience in FDA advertising and promotion and healthcare compliance gained in-house at a pharmaceutical or biotechnology company and/or in a life sciences regulatory practice. Direct experience serving as legal reviewer on promotional review committees (PRC/MRC or MLR). Strong working knowledge of the FDA regulatory framework, the FDCA, Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act/Open Payments, and HIPAA. Strong strategic acumen, with the ability to advise cross-functional clinical, medical, and commercial teams.

The employer's own description, as posted on their site. Apply on Revolution Medicines's site ↗