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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to 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.
Job Description
The Clinical Logistics Coordinator is responsible for investigational product cell journey logistics, chain of custody, and chain of identity. In so doing, this role collaborates with several cross functional stakeholders, including clinical trial personnel, Clinical Operations, Data Management, Clinical Development, Medical Affairs, Regulatory Affairs, Technical Operations, Manufacturing, MSAT, and Quality. This role is a part of the study management team and reports to the Clinical Operations Logistics Manager.
Position Description:
Serves as a primary liaison and clinical trial resource for the screening and enrollment of clinical trial participants across multiple clinical studies.Proactively communicates with site research staff, vendors, and manufacturing to schedule and coordinate the “cell journey” activities as well as initiation/completion of study treatment and subsequent patient visits.Coordinates all aspects of study participant sample collection and “cell journey” including apheresis, shipping, processing, manufacturing and return of investigational product back to the clinical trial sites.Communicates study requirements while ensuring adherence to the cell journey process.Continuously refines and improves the cell journey process including the screening/enrollment of trial patients, patient scheduling and treatment process.Prepares metrics and updates for management as assigned. Proactively identifies potential study issues/risks and recommends/implements solutions.Works with multiple contract research organizations to communicate detailed timelines and ensure that performance expectations are met.Attends internal team meetings, and provides training as necessary at investigator meetings and other trial-specific meetings.Participates in the development, review and implementation of departmental SOPs and processes.Other duties as assigned.Basic Qualifications:
2+ years of relevant clinical or logistics experience, orAny relevant clinical or logistics experience with a BS/BAPreferred Qualifications:
Detail orientedAble to work independently and as part of a teamExcellent verbal and written communicationExperience with Agile change control management a plusExperience with courier servicesExperience with cold chain logisticsExperience with CRM systems: Salesforce, Oracle, SAP a plusExperience with ERP systems: Oracle, SAP a plusFamiliar with domestic and international logistics/transport of biologic material (IATA, ICAO, ADR, DOT, WHO).Knowledge of biological tissue transportation and logisticsOrganized, prioritizes workload, and manages time wellUnderstands basic FDA & EMA regulations, ICH guidelines, and GCPUnderstands basic patient care, treatment scheduling, and managementProficient with Microsoft Word, PowerPoint, and ExcelAdditional Relevant Areas of Experience:
International cold chain logistics involving biologics/live materialInternational cold chain logisticsInternational logistics (non-cold chain)International clinical trial management experienceLocal clinical trial management experience at the trial site levelPharma TechOps/Supply Chain experiencePharma quality and compliance experienceOrgan placement and transplantation experienceEqual Opportunities
As an equal opportunity employer, Gilead Sciences 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 laws. It is also Gilead’s policy to comply with all applicable laws respecting consideration of unemployment status in making hiring decisions.
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If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
About Gilead:
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.