Associate Director, Healthcare Law

Revolution Medicines

1d•$253,000 - $290,000•Remote

About The Position

Revolution Medicines is seeking an Associate Director, Healthcare Law (Brand Counsel) to join its Legal team as the company prepares for indication expansions and launches of daraxonrasib. Reporting to the Senior Director, Healthcare Law, who oversees the daraxonrasib portfolio, this role will serve as lead brand counsel for an assigned indication and therapeutic area, providing legal support from launch readiness through commercialization. The Associate Director will deliver strategic, business-oriented guidance to cross-functional teams and serve as a legal reviewer for promotional and non-promotional materials through the Promotional Review Committee (PRC) and Medical Review Committee (MRC), or MLR review. The role works closely with Commercial, Medical Affairs, Regulatory, Compliance, and other functions, and supports launch readiness, commercialization compliance, training, process improvements, and outside counsel management. Responsibilities may evolve with business needs, and the role offers opportunities to broaden its scope as the daraxonrasib portfolio and Legal team expand.

Requirements

Juris Doctor (JD) degree from an accredited law school.
Active bar membership in good standing in at least one U.S. jurisdiction; candidates based in California must be members of the California bar or eligible to register as Registered In-House Counsel.
At least 8 years of relevant legal experience, including meaningful FDA advertising and promotion and healthcare compliance experience gained in-house at a pharmaceutical or biotechnology company and/or in a life sciences regulatory practice.
Direct experience serving as a legal reviewer on promotional review committees (PRC/MRC or MLR).
Strong working knowledge of the FDA regulatory framework, FDCA, AKS, FCA, Sunshine Act/Open Payments, and HIPAA.
Strong strategic acumen and ability to advise cross-functional clinical, medical, and commercial teams.
Exceptional executive communication, stakeholder management, and negotiation skills, including the ability to explain complex legal risks in clear, business-centric terms.
Collaborative, flexible, and pragmatic work style, with interpersonal skills that build trust and alignment across functions and the ability to thrive in a fast-paced, evolving environment.
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.
Ability to champion Revolution Medicines' values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.

Nice To Haves

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.

Responsibilities

Serve as lead brand counsel and key legal business partner for an assigned daraxonrasib indication, advising cross-functional teams on commercialization matters.
Lead legal launch readiness, including pre-approval communications, development of core claims and launch materials, review of launch campaigns, and coordination with Regulatory on labeling and approval timelines.
Review promotional and non-promotional materials as a legal reviewer on PRC and MRC, including HCP and consumer/DTC, digital, social media, sales training, speaker program, congress/exhibit, and medical scientific exchange materials.
Advise on the boundary 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 AKS, FCA, and Civil Monetary Penalties Law; OIG guidance; and federal and state transparency requirements.
Partner 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, promotion, and healthcare compliance topics, and contribute to review committee process improvements.
Monitor and assess emerging healthcare, drug pricing, supply chain, state law, and FDA enforcement developments, including OPDP untitled and warning letters, and communicate their potential impact on Revolution Medicines.
Manage outside counsel on select healthcare law and commercialization matters.
Support additional Legal team priorities as business needs evolve.