Senior Clinical Project Manager

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Aug 12, 2019
Ref
R0008916
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual to join us as a Senior Clinical Project Manager . You will establish a detailed critical path timeline for multiple studies and are accountable for accurate representation of the clinical demand and study strategic milestones reporting. Interaction with cross-functional development project teams will be required. This is a high impact role integral to the success of the company and will require effective partnerships with the Clinical Development, Manufacturing, Regulatory, Program Management, Research, and Finance. The position will report to the Director of Clinical Program Management.

Responsibilities include but are not limited to:
  • Work with multiple project teams to develop study project plans that delineate team objectives, activities, timelines, and resources required
  • Collaborate with other departments (ie, Commercial, Manufacturing) to ensure alignment on capacity for investigational product supply across the clinical trial portfolio.
  • Partnering with internal cross functional study teams (i.e., Clinical Development, Biometrics, Regulatory Affairs, Safety, Translational Sciences, Clinical Supply Chain etc.) to determine and manage the critical path and from new study concept approval to clinical study report delivery
  • Lead cross-functional team to create detailed timelines that deliver clinical study reports to Regulatory Program Management; you will be responsible for negotiating and accurately determine data availability for all aspects of the study clinical study report
  • Lead the clinical operations standard operating procedures (SOP) workstream to identify and assign department specific SOPs; coordinate cross-functional SOPs; and drive development, review and revision of department specific SOPs.
  • Effectively communicate and manage updates to clinical timeline assumptions to Program management that affect strategic objectives and goals
  • Provide accurate information in company reporting system to drive payments, study status updates, milestone reporting (GILDA)
  • Review, organize, and execute procedures for the Clinical Documents Review Committee
  • Maintain accurate study level clinical demand forecast on a monthly basis
  • Organizes and manages internal team meetings as required to ensure effective and appropriate documentation of decisions, effective communication, and timely completion of action items.
  • Attends cross-functional meetings as needed to represent Clinical Operations Project Management and study-specific issues.
  • Other duties as assigned.


Requirements:
  • At minimum, a bachelor's degree in nursing, science or health related field required
  • At least 2 years of oncology experience
  • At least 3 years of project manager experience in drug development, clinical project management experience highly desirable
  • Experience with transplant patient care, apheresis collection, and/or global filing experience is desirable.
  • Clinical research knowledge and cross-functional understanding of clinical trial methodology
  • Ability to prioritize and execute tasks both as an individual contributor and in a team-based setting
  • History of motivating others to deliver to important milestones while maintaining a positive, transparent and collaborative team environment
  • Capable of assessing and updating detailed project timelines in meetings to guide and align study team members
  • Ability to evaluate meeting minutes and materials for required updates to project timelines
  • Ability to work on complex and multiple projects while exercising critical thinking with minimal supervision
  • Solid attention to detail and excellent organization skills
  • Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members
  • Demonstrates problem solving skills, demonstrates leadership skills, self-motivated and adaptable to a dynamic environment
  • Computer skills including proficiency in the use of Microsoft Project, Word, Excel, PowerPoint, and organization tools
  • Proficient with SharePoint with filing systems is desirable
  • Ability to deal with time demands, incomplete information or unexpected events
  • Must display strong analytical and problem solving skills
  • Outstanding organizational skills with the ability to multi-task and prioritize
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
  • Occasional travel to other company locations as requested.


#LI-JK2

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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