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About the Role

Gilead is dedicated to creating a healthier world by tackling diseases like HIV, viral hepatitis, COVID-19, and cancer through the development of life-changing therapies. We are seeking passionate and ambitious individuals to join our mission and make a direct impact. As a people leader, you will be instrumental in evolving our culture and fostering an inclusive environment where employees are developed and empowered.

Responsibilities

Support clinic logistics as described for previous grade and participate on cross-functional project teams, potentially assigned program management.
Serve as the primary liaison and clinical trial resource for screening and enrollment of clinical trial participants across multiple studies.
Act as a backup liaison and clinical trial resource for screening and enrollment of clinical studies.
Proactively communicate with site research staff, vendors, and manufacturing to schedule and coordinate 'cell journey' activities, study treatment initiation/completion, and subsequent patient visits.
Coordinate all aspects of study participant sample collection and 'cell journey,' including apheresis, shipping, processing, manufacturing, and return of investigational product to clinical trial sites.
Communicate study requirements while ensuring adherence to the cell journey process.
Assist in refining and improving the cell journey process, including patient screening/enrollment, scheduling, and treatment.
Prepare metrics and updates for management, proactively identifying potential study issues/risks and recommending/implementing solutions.
Work with multiple contract research organizations to communicate detailed timelines and ensure performance expectations are met.
Lead internal team meetings and provide training as necessary at investigator meetings and other trial-specific meetings.
Participate in the development, review, and implementation of departmental SOPs and processes.
Create and manage clinical logistics programs as assigned.
Support cross-functional projects.
Travel as required.
Perform other duties as assigned.

Requirements

At least 4 years of experience with a BS or BA in a relevant scientific discipline, or 3 years with an MS/MA in a relevant discipline, or at least 4+ years of relevant clinical or logistics coordinator experience.
Ability to work with multiple database and electronic systems; experience with Oracle/ERP, courier, and material ordering portals is a plus.
Strong analytical and problem-solving skills with attention to detail.
Outstanding organizational skills with the ability to multitask and prioritize.
Excellent interpersonal, verbal, and written communication skills.
Comfortable working in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.
Knowledge of clinical trials and logistics to assist project teams.
Knowledge of FDA and ICH requirements as they pertain to clinical trials.
Knowledge of domestic and international logistics/transport of biologic material (IATA, ICAO, ADR, DOT, WHO).
Ability to manage processes and teams.
Ability to author documents.
Ability to present at study meetings.
Ability to partner with other functions.

Skills

Clinical Logistics
Clinical Trial Management
Cross-functional Team Collaboration
Program Management
Communication (Verbal and Written)
Analytical Skills
Problem-Solving
Organizational Skills
Multitasking
Prioritization
Interpersonal Skills
Process Improvement
Metrics Reporting
Risk Management
Vendor Management
FDA Regulations
ICH Guidelines
IATA
ICAO
ADR
DOT
WHO

Location

Remote

Work Type

Full-time

Experience Level

Mid-level

Education Level

BS/BA in a relevant scientific discipline
MS/MA in a relevant discipline

About the Company

For more than 35 years, Gilead has tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer, working relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.
We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations.
Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
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 Gilead and help create possible, together.