Senior Clinical Trial Manager Late Phase

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

Gilead Sciences Inc. is a research-based biopharmaceutical company that discovers develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate we seek to improve the care of patients suffering from life-threatening
diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS hepatitis serious respiratory cardiovascular and metabolic conditions cancer and inflammation.

Kite a Gilead Company is a biopharmaceutical company that is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.
We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment where we make discoveries every-day discoveries that include our own capabilities and our individual potential.

The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials across all therapeutic areas around the partnership with Clinical Research Medical Affairs and other Development Operations functions Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialization of Gileads products.

An exciting and challenging opportunity has arisen to join the Clinical Operations team based in Santa Monica as a Senior Clinical Trial Manager specializing in Late Phase studies.

Essential Duties and Job Functions:

• Responsible for the planning execution and oversight of global and regional Late Phase studies including Phase IV non-interventional observational real-world evidence (RWE) registry and post-marketing safety/effectiveness studies.
  Drafts and coordinates review of relevant documents including protocols informed consents case report forms monitoring plans investigator brochures and clinical study reports.
  Develop and Maintains study timelines and risk mitigation plans.
  Contributes to development of study budget.
  Contributes to development of RFPs and participates in selection of CROs/vendors.
• Provides strategic oversight and guidance for global late phase studies
  Coordinates review of interim/final clinical study reports.
  Ensures effectiveness of site budget/contract processes
• May be asked to train CROs vendors investigators and study coordinators on study requirements.
  Assists in determining the activities to support a projects priorities within functional area.
• Partners with Clinical Program Managers and Managers in other functions providing input where key decisions impacting business operations will be made.

Specific Responsibilities:
Works with Clinical Program Managers to lead operational planning and execution of global/regional late phase studies with latitude for independent judgment and decision-making within defined guidelines.

Excels in project management and demonstrates ability to take on more studies and/or studies of greater complexity Understands how the design and operations of late phase studies impact the goals of various functions.

In partnership with CPMs provides guidance and daily oversight for the successful
management of all aspects of late phase studies within designated program budgets and timelines.
Contributes to development of abstracts presentations and manuscripts.

Basic Requirements:

• Masters and 4 years of related experience OR
• Bachelors and 6 years of related experience OR
• High School Diploma and 11 years of related experience

Preferred Requirements:
Educated to degree level or above within a scientific discipline
Oncology and Cell Therapy/ATIMP experience is desirable

Previous study management experience at trial management level preferably in a late phase setting
Previous monitoring experience is desired but not essential for the role
Line management is desired but not essential
Thorough knowledge and understanding of FDA Regulations GvP and clinical trial conduct standards
experience interpreting and explaining protocol requirements to others

Excellent functional expertise to support SOP development and implementation
Excellent teamwork decision-making communication and organizational skills

Gilead & Kite Core Values
Integrity (always doing the right thing)
Teamwork (collaborating in good faith)
Excellence (working at a high level of commitment and capability)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)

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.