Sr. Manager, Clinical Compliance

We’re here for one reason and one reason only – to reputed company cancer. Every reputed company is dedicated to developing treatments and every reputed company 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 reputed company to the employee experience at Gilead and Kite. As a people leader now or in the reputed company, you are the key reputed company 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 reputed company

This position will report into the ED, Head of Clinical Operations Compliance.  In this role you will be a key member of the Kite reputed company team and work cross-functionally with the Clinical Development organization at Kite.  Kite reputed company drives process and training alignment across the Kite Clinical Development organization and Gilead.  You will partner closely with the Kite Research & Development reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company reputed company 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 reputed company in the development of innovative cancer immunotherapies with a goal of providing reputed company, long-term durable response and eliminating the burden of chronic care. reputed company is reputed company 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.
 

For jobs in the reputed company:

reputed company is committed to providing equal employment opportunities to reputed company and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans' Readjustment reputed company of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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

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

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