Assoc Director, Clinical Records

Associate Director, Clinical Records & Information Management

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.

The Associate Director, Clinical Records & Information Management is responsible for partnering with cross-functional teams, Clinical Research Organizations (CROs), and Functional Service Providers (FSPs) to ensure Trial Master File (TMF) compliance with industry standards and regulations. This role supports inspection readiness across the clinical portfolio and leads TMF integrations and migrations for acquired assets, divestitures, and partnerships.

Primary Responsibilities :

• Lead end-to-end TMF migrations and integrations for acquisitions, divestitures, and partnerships
• Oversee TMF quality checks for inspection readiness and audit / inspection preparation
• Ensure standardized TMF practices across clinical trial teams
• Supervise clinical teams and external vendors to maintain document compliance with ICH-GCP and SOPs
• Partner with Quality Assurance / Compliance teams for risk mitigation, CAPAs, and issue resolution
• Collaborate with stakeholders to align processes and prioritize system improvements
• Participate in internal initiatives to enhance operational excellence and inspection readiness
• Analyze data and audit outputs to identify trends and develop process improvements
• Ensure availability of reports and dashboards in eTMF systems
• May recruit, hire, mentor, and manage direct reports
• Communicate effectively to provide clear direction and influence stakeholders

Basic Qualifications :

Preferred Qualifications :

People Leader Accountabilities :

Does this sound like you? If so, apply today!