Manager, Research Business Management, Kite Research Strategic Operations

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 14, 2020
Ref
R0015341
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Kite, a Gilead Company, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower 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.

Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Manager, Research Business Management, Kite Research Strategic Operations (Manager, Project Management)

Responsibilities (include but are not limited to):
  • Oversees and manages the biological sample management requirements of several clinical trials within and across development programs
  • Collaborates with Clinical Operations and Translational Sciences on biological sample management tracking and issue resolution
  • Understands the Translational Sciences biomarker sample analysis plans and coordinates across multiple clinical programs
  • Provides input in the development and review of biomarker related content within protocols and supports development of informed consent forms
  • Collaborates with Clinical Operations and Translational Sciences on request for proposals, budget review, vendor selection, review and development of the scope of work/laboratory services specification documents and site facing laboratory manuals
  • Maintains laboratory processing instructions for consistency across programs, and supports revisions as necessary
  • Has a basic understanding of sample collection, processing protocols and shipping conditions
  • Understands and has ability to navigate various central laboratory sample management systems to enable generation of sample inventory reports for tracking and placing sample orders
  • Understands and has ability to navigate the Kite Laboratory Information Management System (LIMS)
  • As needed, places sample orders ensuring specific analysis is permitted per the protocol and informed consent form (ICF) (eg, consent to optional biomarker analysis; tracking of individual subject consent status)
  • Reconciles discrepancies in sample orders received by Kite or external contract research labs and is able to troubleshot other issues as they arise; collaborate with Clinical Operations as needed
  • Reviews biomarker text in site specific ICF's as requested
  • Assists in addressing site and/or IRB/EC/IBC questions regarding biomarker sample management
  • Understands program specific deliverables (eg, analysis, data cut-off timelines) and collaborates with the study teams on development of study specific timelines for laboratory sample analysis and data transfer
  • Attends study team meetings as needed
  • Assists study team(s) with unique ad hoc requests for sample analysis
  • Reviews and performs quality control of laboratory data in preparation for analysis
  • Provides input into the development of study specific important protocol deviation lists as they relate to biomarker analysis
  • Light travel 10% or as needed
  • Other duties as may be assigned


Requirements:
  • Bachelor's degree in biological sciences (preferred) (7+ Years with BS/BA, 5+ Years with MS/MA)
  • 2+ years of industry sample management experience or equivalent
  • Excellent interpersonal, verbal and written communication skills
  • Basic understanding of clinical trial conduct
  • Ability to communication cross functionally
  • Organized with ability to multitask and prioritize effectively
  • Detail oriented
  • Self-motivated
  • Computer skills: Knowledge of Microsoft Office, Excel, Laboratory Information Management Systems; ability to navigate and learn systems (eg, central laboratory system); Preferred: Spotfire


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 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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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.