Associate Director, Clinical Operations Connect GCP Excellence and Inspection Readiness

Gilead Sciences, Inc.•Foster City, CA

59d

About The Position

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 Overview: The Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients. The Connect function within the CTC organization is a centralized process department that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations. The Associate Director will be a key member of the Connect GCP Excellence and Inspection Readiness (GEIR) team and collaborate with Clinical Operations personnel to ensure quality, proactively identify risk, mitigate non-compliance, and support deviation management activities. The position will partner closely with Research & Development Quality personnel.

Requirements

BA or BS and 10+ years' experience in compliance in pharmaceutical / biotechnology industry OR Masters and 8+ years' experience in compliance in pharmaceutical / biotechnology industry
Project management experience and demonstration of proactive timeline management and driving teams to achieve timelines.
Excellent working knowledge of FDA, EMA, and ICH GCP and other applicable regulations governing the conduct of clinical studies.
Ability to build strong relationships to foster a collaborative approach to proactive compliance activities.
Strong verbal, written, communication, and interpersonal skills.
Strong leadership presence with demonstrated ability to lead without authority.
Ability to analyze complex situations, develop multiple options/solutions within regulatory guidance.

Responsibilities

Lead efforts to increase a culture of quality within the Clinical Operations organization.
Collaborate with Clinical Operations to confirm adherence to GCP compliance execution through all stages of clinical trial conduct including but not limited to core study execution, clinical trial sponsor oversight, deviation management and internal audit support.
Lead Clinical Operations on internal deviations activities, including project management support for deviation management activities.
Provide guidance for investigations, root cause analysis, development of corrective and preventive action (CAPA) plans for deviations and/or observations of non-compliance.
Lead the internal audit/deviation response process within Clinical Operations and follow response/CAPA commitments to completion.
Gather, analyze and share best practices and lessons learned from audit, inspection, and deviation activities for Clinical Operations.
Work with relevant stakeholders to identify areas for improvement from audits, inspections, deviations, and corresponding appropriate next steps.
Compile and communicate quality related metrics, risks, and quality challenges to teams and management.
Determine, develop, execute Effectiveness Checks for applicable CAPAs.

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