Assoc Director, Clinical Records

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 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:

• Doctorate and 5+ years of compliance and TMF within the pharmaceutical/biotech industry experience OR
• Master’s and 8+ years of compliance and TMF within the pharmaceutical/biotech industry experience OR
• Bachelor’s and 10+ years of compliance and TMF within the pharmaceutical/biotech industry experience

Preferred Qualifications:

• Deep knowledge of TMF Reference Model, ALCOA+ standards, Expected Document Lists (EDLs), ICH-GCP, and Good Documentation Practices
• Experience with Veeva Clinical Vault (eTMF/CTMS); Vault Admin Certification preferred
• Strong commitment to quality and compliance
• Skilled in project and resource management, strategic planning, and deployment
• Ability to analyze complex regulatory scenarios and develop compliant solutions
• Strong change management and conflict resolution skills
• Capable of working independently within a broad regulatory framework
• Excellent verbal, written, interpersonal, and presentation skills

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem

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

 

The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This posi