Clinical Program Manager, Clinical Operations

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 16, 2020
Ref
R0015104
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

We are seeking a highly motivated individual to join us as a Clinical Program Manager , Clinical Operations. You will manage multiple study teams across a program and ensure consistency and quality in all aspects of Kite clinical trials. The candidate must have prior experience managing direct reports and be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to the Director of US Clinical Operations.

NOTE : This position can be located onsite in Santa Monica, CA, Foster City, CA, Seattle, WA or work Remote.

Responsibilities include but are not limited to:
  • Accountable for all operational aspects of clinical trials within the assigned program
  • Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
  • Examine functional issues from a broader organizational perspective and develop a strategy to implement with a cross-functional team
  • Provides program level oversight to vendors, including CRO, central lab, and imaging.
  • Proactively identifies potential issues/risks across the program and recommends/implements solutions.
  • Participates in the selection, training and evaluation of clinical trial managers and clinical trial management associates to ensure the efficient operation of the function.
  • Leads the development, review and implementation of departmental SOPs and processes.
  • Attends and presents at cross-functional meetings as needed to represent Clinical Operations and program level items
  • Provides mentorship and career development to direct reports.
  • Provides leadership to the clinical operations team working on the assigned program.
  • Other duties as assigned.


Requirements:
  • At minimum, a bachelor's degree in nursing, science or health related field required
  • At least 7 years of related clinical trial management experience. Knowledge of oncology, transplant patient care, and apheresis collection a plus.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficient in developing trial plans and implementing operational changes across multiple studies
  • Highly developed leadership skills to successfully lead multiple direct reports
  • Must display strong analytical and problem solving skills at a program level and collaborate with colleagues to generate solutions
  • Strong communication and influence skills and ability to create a clear sense of direction
  • Ability to deal with time demands, incomplete information or unexpected events
  • Outstanding organizational skills with the ability to multi-task and prioritize
  • Attention to detail required
  • Must be willing to travel at least 25% (possibly more)
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities


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.