Role Description
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, 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
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Serve as lead brand counsel and key legal business partner for an assigned daraxonrasib indication.
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Partner with Commercial, Medical Affairs, Regulatory, Compliance, and other functions to provide practical, risk-calibrated advice on commercialization matters.
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Lead legal launch readiness for the assigned indication, including:
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Pre-approval communications
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Development of core claims and launch materials
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Review of launch campaigns
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Coordination with Regulatory on labeling and approval timelines
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Serve as legal reviewer on PRC and MRC, reviewing promotional materials and non-promotional/medical scientific exchange materials for compliance.
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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.
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Advise on the FDCA and related FDA regulations and guidance; fraud and abuse laws; and federal and state transparency requirements.
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Coordinate with Compliance to operationalize compliance in commercial activities.
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Provide strategic legal advice on patient support programs, hub services, copay and patient assistance programs, independent charitable foundations, and market access and payor materials.
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Develop and deliver training to brand, commercial, and medical teams on advertising and promotion and healthcare compliance topics.
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Participate in monitoring and assessing emerging healthcare, drug pricing, supply chain, state law, and FDA enforcement developments.
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Manage outside counsel on select healthcare law and commercialization matters.
Qualifications
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Juris Doctor (JD) degree from an accredited law school.
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Active bar membership in good standing in at least one U.S. jurisdiction.
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8+ years of relevant legal experience, including meaningful experience in FDA advertising and promotion and healthcare compliance.
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Direct experience serving as legal reviewer on promotional review committees (PRC/MRC or MLR).
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Strong working knowledge of the FDA regulatory framework, the FDCA, Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act/Open Payments, and HIPAA.
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Strong strategic acumen, with the ability to advise cross-functional clinical, medical, and commercial teams.
Preferred Skills
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Experience supporting product launches, including indication expansions.
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In-house experience supporting commercial-stage marketed products.
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Oncology or specialty/rare disease experience.
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Experience with patient support, hub, copay/patient assistance, and market access programs.
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Experience with digital and social media promotion.
Key Competencies
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Exceptional executive communication, stakeholder management, and negotiation skills.
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Collaborative, flexible, and pragmatic work style.
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Business partnering mindset—solutions-oriented, risk-based judgment.
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Ability to manage high volume and competing priorities with sound judgment.
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Ability to maintain confidentiality and operate with high ethical standards and professionalism.
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Champions RevMed’s values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.
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.
Base Pay Salary Range
$253,000 — $290,000 USD