Director, Medical Affairs Framework

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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 experie