Associate Director, Clinical Operations Connect GCP Excellence and Inspection Readiness

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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.

Primary 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.

Qualifications:

• 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.

For additional benefits information visit:

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

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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 apply via the Internal Career Opportunities portal in Workday.