Director, Medical Affairs Framework

* Identify and share opportunities to improve specific Medical Affairs framework, policies and input into relevant global and local policies.* Develop, lead, and continuously improve the U.S. Medical framework to support compliant medical operations and decision-making.* Drive medical affairs framework and ethical training programs and ensure ongoing training within USMA and US Affiliate as required.* Ensure appropriate onboarding of employees into USMA framework in collaboration with Global Learning and Development.* Ensure an effective medical contribution to the review and approval processes for U.S. promotional and non-promotional materials, ensuring medical accuracy and compliance (PRC).* Ensure an effective medical contribution to the U.S. Medical Review Committee (MRC), ensuring timely and compliant review of medical content.* Manage the USMA input into PRC and MRC escalation* Collaborate closely with U.S. Commercial, Regulatory, Legal, and Compliance teams to support business objectives while upholding medical affairs framework standards.* Ensure adherence to U.S. regulatory and industry standards including FDA promotional guidelines, PhRMA Code, and OIG compliance requirements.* Provide medical governance oversight for U.S. medical field activities (e.g., MSL engagements, scientific exchange, advisory boards, investigator-sponsored studies).* Support audits and inspections as needed.* Up to date on emerging global and U.S. regulatory, clinical, ethical and compliance trends and assess their impact on USMA framework.* Act as key liaison between Medical Affairs, Regulatory, Legal, Compliance and Commercial teams to ensure medical affairs has the optimal framework to enable compliance and USMA deliverables.* Oversee risk assessments and implement control measures for emerging issues and manage medical and scientific risks across the US Affiliate.* Develop appropriate metrics and dashboards to reflect key performance indicators for effective Medical Affairs framework within the US.* Advanced degree in a life science discipline (MD, PharmD, or PhD strongly preferred).* Minimum 5 years of experience in U.S. Medical Affairs roles within the pharmaceutical or biotech industry.* Deep understanding of US FDA regulations, PhRMA Code, Sunshine Act, and other applicable laws and guidance.* Proven understanding or ability to lead governance frameworks within a US-based, cross-functional Medical Affairs environment.* Strong experience in promotional review committees and medical content governance.* Exceptional interpersonal, influencing, and communication skills.* Strategic mindset with the ability to navigate complex challenges and drive ethical, compliant decision-making.Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans\*.

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