Biomarker Sample Operations Lead

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview 

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Biomarker Sample Operations Lead. This role will oversee clinical sample life-cycle management, from multiple global clinical trials, internally and across external labs and third-party vendors. This position will report to the Executive Director, Data Management.  

The candidate will partner with Clinical Operations, Data Management, Clinical Development, and Translational Medicine team members to build, implement, and manage the end-to-end clinical PK and Biomarker sample logistics. The candidate will ensure that the PK and Biomarker analysis samples are accurately acquired, processed, and prepared for contracted laboratory analysis.  The responsibility spans from the initial operationalization of the clinical protocol through site-facing instructional documentation to the delivery of precisely processed samples to the final analysis lab. The work will come through global and local implementation, including collaboration with large central and more specialized analysis lab vendors for study setup, sample monitoring, and eventual data reporting per data transfer agreement development.   

Job Duties and Responsibilities 

• Oversee clinical PK and Biomarker sample management and chain-of-custody in a GxP compliant setting, including sample processing, collection, storage, and distribution. 

• Contributes to the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics and shipping as needed  

• Contributes to generation of study related training for the study team, study sites and vendors for each trial. This may include development of site qualification requirements for sample processing or conduct of site facing training on sample collection procedures.  

• Develops site facing instructions (e.g., Lab Manual) to ensure accurate PK & Biomarker sample collection and processing at sites. 

• Coordinate sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct database. 

• Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines 

• Participate in implementation of technologies/tracking solutions that ensure sample chain of custody and data integrity.  

• Manage and mon