Clinical Logistics Manager

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Aug 28, 2020
Ref
R0014546
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 as a Clinical Logistics Manager within Clinical Operations. You will manage and oversee all aspects of clinical trial logistics including program management and implementation, study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, import/export requirements of biologics to include but not limited genetically modified organisms, be familiar with and able to interpret and apply global tissue/cell transplant regulations, as well as possess a comprehensive understanding of global transportation regulations of goods both infectious and non-infectious. The position will report to the department Associate Director.

Responsibilities include but are not limited to:
  • Manages and supports the clinical logistics team to ensure operations align with broader clinical trial goals.
  • Ensures consistent execution of clinical logistics programs and processes across all studies in conjunction with management.
  • Ensures that personnel are selected, trained and developed to meet clinical logistics needs.
  • Manages clinical logistics training, mentorship and performance reviews for direct reports.
  • Identifies potential study and logistics issues/risks and recommends and implements solutions.
  • Assists with managing budget and resources according to team priorities/need.
  • Works with manufacturing, quality, supply chain, investigational sites, CROs, CMOs, vendors, certified suppliers couriers, and others to ensure logistical operational expectations are met.
  • Provides guidance to logistics staff to resolve day-to-day enrollment and cell journey issues.
  • Identifies, monitors and updates management regarding clinical logistics issues.
  • Serves as a cross-functional resource for clinical trials enrollment and cell journey management expertise.
  • Prepares and appraises documents affecting logistics operations, i.e. clinical protocols, IPM, IPM forms, commercial invoices, vendor client operating procedures, etcetera.
  • Prepares metrics and updates for the team and management.
  • Participates in the development, review and implementation of departmental SOPs and processes.
  • Accountable for implementation of study enrollment initiatives and cell journey timeline.


Requirements:
  • At least 7 years of experience with a BS/BA or 5+ years with a MS/MA in a relevant discipline or 10+ years of relevant clinical or logistics coordinator experience.
  • Knowledge of FDA and ICH requirements as they pertain to clinical trials.
  • Understanding of domestic and international transport of biologic material (IATA, ICAO, ADR, DOT, WHO).
  • Experience with clinical logistics operational management
  • Experience with team management and career development.
  • Excellent written and verbal communication
  • Demonstrates knowledge of how clinical trial operations and logistics impact broader strategic goals at Kite.
  • Excellent negotiating and interpersonal skills.
  • Ability to travel nationally and internationally as needed.
  • Understands, interprets and is able to explain protocol requirements to others.


#IND123

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.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic 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 laws. In 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 contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

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