Associate Director, Healthcare Law

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.

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, state 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.

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.

Preferred Skills

• Experience supporting product launches, including indication expansions.
• In-house experience supporting commercial-stage marketed products.
• Oncology or specialty/rare disease experience.
• Experience with patient support, hub, copay/patient assistance, and market access programs.
• Experience with digital and social media promotion.

Key Competencies

• Exceptional executive communication, stakeholder management, and negotiation skills, with the ability to convey complex legal risks in clear, business-centric terms.
• Collaborative, flexible, and pragmatic work style, with interpersonal skills that inspire trust and alignment across functions and the ability to thrive in a fast-paced, evolving environment.
• Business partnering mindset—solutions-oriented, risk-based judgment that enables business objectives.
• Ability to manage high volume and competing priorities with sound judgment and timely turnaround.
• Ability to maintain confidentiality and operate with high ethical standards and professionalism.