Director, Medical Affairs Framework

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Job Description

The Director USMA (United States Medical Affairs) Framework Architecture is responsible for establishing maintaining and continuously improving the medical affairs framework within US Medical Affairs. This role ensures medical affairs operates ethically transparently and in full compliance with internal policies industry codes and regulatory requirements. This role oversees the design and implementation of robust medical mechanisms for medical content scientific exchange evidence generation and external engagement to uphold the highest ethical standards patient-centricity and scientific integrity.

Develop and execute training programs for Medical Affairs personnel on Medical Affairs framework and ethical standards. Track training completion and maintain audit readiness documentation. Ensure USMA employees operate in the appropriate framework for all US medical activities including publications post approval studies investigator-initiated research advisory boards scientific engagement and medical information and response documents. Partner with patient safety organization. Ensure Scientific integrity in US Affiliate communication.

Contribute to shaping medical affairs framework that compliantly enables the US Medical Affairs and US Affiliate organization.

Key Responsibilities:

• 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.

Qualifications:

• 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.

The salary range for this position is:

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*.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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