Biosample Operations Lead for Translational Medicine

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 114,000 - 149,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Other benefits

Job summary

Denali Therapeutics Inc. is a biotechnology company focused on advancing clinically validated transport technologies for CNS disease. The role guides BSO systems and tools within Biorepository and Clinical Study Management to ensure data integrity and sample governance.

You will mentor staff, coordinate with scientists, CROs and vendors, and drive continuous improvements to biospecimen handling, data transfer, and SOP updates while ensuring GCP and GDPR compliance.

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field, with a minimum of 5 years of experience in Translational Medicine or Clinical Development, or related field/training
• Experience with human biosample management, regulatory compliance, and quality assurance in a clinical trials/drug-development setting
• Proficient in LIMS database entry, advanced Excel, and interpreting Clinical Research Protocols
• Ability to work effectively in a cross-functional team matrix environment
• Strong customer-service focus with advanced planning and organizational skills; adapts quickly to shifting priorities and deadlines

Responsibilities

• Management of software containing clinical biospecimen data in close collaboration with Biorepository staff, Clinical Study Management, Data Management and Clinical Programming
• Responsible for ongoing maintenance and improvements of BSO systems and tools, as necessary
• Ensure sample integrity and maintain GCP and GDPR compliance for clinical trial samples through chain of custody, sample handling guidelines, and proper storage conditions
• Responsible for design and build of study collection plans to allow real-time import of incoming samples into LIMS. This requires coordination with scientists, CROs and vendors and ability to interpret clinical research protocols.
• Responsible for vendor management and oversight of BSO managed vendors
• Mentor and train BSO staff, train relevant functional groups in BSO procedures, and participate in the creation and updating of BSO SOPs
• Management of biomarker studies and collaborations, and support of clinical study management projects
• Lead process improvement projects to enable efficiency and innovation in BSO processes
• Review and approve Data Transfer Specifications, custom manifests, import files, and other sample data collection documents.

Education

Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field

Tools

LIMS

Excel

Job description

Denali Therapeutics Inc. is a biotechnology company focused on advancing clinically validated transport technologies for CNS disease. The role guides BSO systems and tools within Biorepository and Clinical Study Management to ensure data integrity and sample governance.

You will mentor staff, coordinate with scientists, CROs and vendors, and drive continuous improvements to biospecimen handling, data transfer, and SOP updates while ensuring GCP and GDPR compliance.