Sr. Manager, Clinical Compliance

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.

Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

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 Kite and help create more tomorrows.

Job Description

This position will report into the ED Head of Clinical Operations this role you will be a key member of the Kite Align team and work cross-functionally with the Clinical Development organization at Kite. Kite Align drives process and training alignment across the Kite Clinical Development organization and Gilead. You will partner closely with the Kite Research & Development Quality team and central process teams at Gilead.

Key Responsibilities:
Drive the development optimization alignment and implementation of clinical trial processes across Kite Clinical Development
Partner with equivalent Gilead functions for development optimization and alignment of shared clinical trial processes
Identify and Lead Process Improvement opportunities at Kite
Provide Kite Clinical Operations SME support to the Gilead PROGRESS and POM teams
Establish and maintain the training curricula for Clinical Operations (inclusive of Clinical Operations Data Management and Clinical Logistics) and support other Clinical Development functions as needed
Develop Onboarding plans for Clinical Operations
Support transition planning within Clinical Operations as needed
Proactively monitor compliance with Clinical Operations procedural documents and training requirements
Develop and report process and training compliance metrics
Support and participate in internal audits and regulatory authority inspections as needed
Support audit/inspection response development and CAPA implementation
Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to ensure Clinical Development processes are updated as necessary
Lead and support efforts to increase compliance awareness and a culture of compliance
Basic Qualifications:
Demonstrated ability to lead.
BS or BA in a relevant scientific discipline and 8 years of experience OR RN (2 or 3 year certificate) and 8 years of experience.
Must be able to resolve problems using national and international regulations guidelines and investigator interaction.
Thorough knowledge and understanding of FDA and/or EMEA Regulations ICH Guidelines and GCPs governing the conduct of clinical trials is required.
Functional expertise to initiate author or contribute to SOP development implementation and training.
Demonstrated understanding of end-to-end clinical trial processes.
Preferred Qualifications:
Strong communication and influence skills and ability to create a clear sense of direction.
Ability to examine functional issues from a broader organizational perspective.
Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.

For additional benefits information visit:

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

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Kite Pharma 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.

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Kite Pharma 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.

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

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.