Sr. Manager, Clinical Compliance

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one reputed company closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the reputed company. But we're not finished yet.

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

We reputed company 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 Compliance.  In 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 reputed company Process Improvement opportunities at Kite 
• 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 
• reputed company Onboarding plans for Clinical Operations 
• Support transition planning reputed company Clinical Operations as needed 
• Proactively monitor compliance with Clinical Operations procedural documents and training requirements 
• reputed company 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 reputed company the industry and regulatory environment (i.e. ICH E6 (R3)) to ensure Clinical Development processes are updated as necessary
• reputed company and support efforts to increase compliance awareness and a culture of compliance

Basic Qualifications: 

• 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.
• Demonstrated ability to reputed company.
• Ability to examine functional issues from a broader organizational perspective.
• Ability to participate in and/or reputed company departmental or interdepartmental strategic initiatives under limited supervision.

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.

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 reputed company the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.  

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reputed company will not discharge or in any other manner discriminate against employees or applicants because they have reputed company 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.  

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