Job Description

Job Description

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.

The Clinical Logistics Specialist 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.

Responsibilities (include but are not limited to):

• Supports clinics logistics as described for previous grade. Participates on cross-functional project teams and may be assigned program management.
• Serves as primary liaison and clinical trial resource for the screening and enrollment of clinical trial participants across multiple clinical studies.
• Serves as back up liaison and clinical trial resource for the screening and enrollment of 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.
• Assists in the refinement and improvement of 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.
• Leads 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.
• Creates and manages clinical logistics programs as assigned.
• Supports cross functional projects.
• Travels as required.
• Other duties as assigned.

Basic Qualifications:

• 6+ years of relevant clinical or logistics experience
• 4+ years of relevant clinical or logistics experience with a BS/BA
• 2+ years of relevant clinical or logistics experience with a MS/MA

Preferred Qualifications:
• Ability to work with multiple database and electronic systems. Experience with Oracle/ERP, courier, and material ordering portals, considered a plus
• Must display strong analytical and problem-solving skills. Attention to detail required.
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Possesses knowledge of clinical trials and logistics and can assist project teams with this knowledge.
• Knowledgeable of FDA and ICH requirements as they pertain to clinical trials.
• Knowledgeable of domestic and international logistics/transport of biologic material (IATA, ICAO, ADR, DOT, WHO).
• Excellent written and verbal communication is a pre-requisite.
• Ability to manage processes and teams
• Ability to author documents
• Ability to present at study meetings
• Ability to partner with other functions

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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