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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 reports to Global Head, Clinical Records and Information Management, partnering with cross functional teams as well as Clinical Research Organizations (CRO) and Functional Service Providers (FSP) to ensure TMF compliance with industry standards and regulations with the goal of Inspection Ready for clinical studies.

This role is a member of the Clinical Records leadership team accountable for end to end delivery of TMF integrations/migrations for acquired assets, asset divestiture and partnerships and Inspection Readiness across the clinical portfolio.

The ideal candidate will have a proven track record of innovation and creative solutions to deliver on business expectations, improve overall TMF Compliance and Inspection Readiness capabilities.

PRIMARY RESPONSIBILITIES:

Lead end to end TMF migrations and integrations in support of asset acquisitions, divestitures and partnerships
Oversee standards and process to partner with study teams to conduct quality checks of the TMF for inspection readiness and audit/inspection preparation, with regulations, ICH guidelines, and internal procedural requirements
Oversee standardized TMF practices across clinical trial teams to ensure consistency and adherence to best practices
Responsible for overseeing the activities of clinical teams and external vendors ensuring study documents are managed with adherence to ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready
Partner with Quality Assurance/Compliance teams in support of risk mitigation strategies, corrective and preventative actions, and issue resolution, along with proactively communicating changes, updates, and issues to TMF stakeholders
Collaborate with key internal and external stakeholders to assess process alignment and prioritize procedural and TMF system changes to ensure continued improvements and compliance
Participate in internal process improvement projects/initiatives to continuously improve operational excellence in support of inspection readiness
Review data quality outputs and audit outputs to identify trends; develop process improvements, includes reviewing and reporting metrics established for performance TMF reviews and providing action plans as appropriate
Proven ability to drive process improvements and manage multiple projects simultaneously
Ensures reports and dashboards are developed and available for teams in eTMF
May recruit, hire, mentor, and manage direct reports and support their professional development.
Strong communication and influence skills and ability to create clear sense of direction is necessary.
Excellent verbal, written, interpersonal and presentation skills are required.
Extensive knowledge and understanding of FDA, EMEA, ICH, GCPs governing the maintenance of clinical TMF.

QUALIFICATIONS:

BA or BS and 12+ years' experience in compliance and trial master file in pharmaceutical/biotechnology industry.
Excellent working knowledge of the TMF Reference Model, ALCOA+ standard, Expected Document Lists (EDLs) and Milestones, ICH-GCP guidelines, and Good Documentation Practices
Direct experience with Veeva Clinical Vault (eTMF/CTMS) - Vault Admin Certification preferred
A passion for quality and compliance.
Project management, resource management and planning
Strategic thinker with ability to develop and deliver to a high level strategy and deployment plans
Ability to analyze complex situations, develop multiple options/solutions within regulatory guidance.
Strong change management skills and conflict resolution skills are essential. Ability to remain focused in high-stress situations.
Ability to work independent, within a broad regulatory framework
Strong verbal, written, communication, and interpersonal skills.

The salary range for this position is: $173,910.00 - $225,060.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantA[redacted] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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