About this role
About the Role
Senior Counsel - Legal Business Partner for U.S. Medical Affairs (USMA) Virology to support USMA Virology with a focus on HIV. You will serve as the lead legal partner providing strategic legal guidance to enable development and commercialization of Gilead products, while collaborating closely with the USMA team to balance risk with medical decision-making in a fast-paced, regulated environment. What You'll Do
-
Serve as the primary legal business partner to USMA home office strategy and field medical teams, collaborating with Global Medical Affairs at both strategic and operational levels.
-
Provide legal guidance on USMA strategies and activities related to non-promotional scientific exchange (proactive and reactive), medical education, and engagements with healthcare providers and other scientific stakeholders, ensuring compliance with applicable healthcare laws and company policies.
-
Advise on a broad range of legal and compliance matters, including FDA requirements, the False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, etc to identify, assess, and mitigate risk across Medical Affairs activities.
-
Provide legal support for US based evidence-generation and research initiatives, including investigator-initiated studies, collaborative research projects, advisory and insights programs, and HEOR studies, ensuring adherence to regulatory, ethical, and internal governance requirements.
-
Advise on legal risk for USMA external engagement activities, including advisory boards, scientific congresses, publication planning, professional society and patient advocacy engagement and medical education programs, ensuring these activities remain compliant with applicable laws, regulations, and policies.
-
Review scientific and educational materials as a member of the Medical Review Committee, advising on innovative scientific content (including digital formats), supporting data readouts, medical launch activities, and major scientific congresses, and delivering training at key internal meetings.
-
Partner closely with colleagues in Compliance, Privacy, Competition Law, Regulatory, Corporate and other functions to support compliant Medical Affairs operations and resolve cross-functional issues efficiently.
-
Monitor developments in healthcare laws, regulations, and industry guidance impacting Medical Affairs and proactively communicate implications and best practices to internal stakeholders.
-
Operate with a proactive, solution-oriented mindset, demonstrating strong collaboration, sound judgment, and the ability to manage multiple complex initiatives across teams and geographies in a fast-paced, highly regulated environment. What We're Looking For
-
Juris Doctorate from an accredited law school and 8 years experience.
-
Admitted to practice law in at least one U.S. state and in good standing, or eligible for in-house counsel registration or fully qualified legal credentials in geography of operations.
-
10+ years of industry and/or law firm experience providing legal counsel relating to biotechnology, pharmaceutical, or therapeutic products, preferably including in-house experience.
-
Advanced knowledge of U.S. healthcare and compliance laws and regulations, including FDA regulations, fraud and abuse laws, applicable industry codes as well as general understanding of regulatory, intellectual property, privacy, and understanding of contract provisions.
-
Demonstrated experience supporting the Medical Affairs function, including non-promotional scientific exchange and field medical activities.
-
Experience advising cross-functional review committees, such as Medical Review Committees, or similar governance bodies.
-
Ability to operate effectively in a fast-paced, evolving regulatory environment with high accountability and emotional intelligence. Nice to Have
-
In-house experience within a pharmaceutical/biotech environment.
-
Experience leading complex transactions or programs involving scientific communications, medical education, or advisory boards.
-
Strong la w firm background with exposure to US regulatory and commercial topics in Medical Affairs. Compensation & Benefits
Not disclosed in the posting.