Biosample Operations Associate
Denali Therapeutics
Summary
This individual will guide efforts to increase productivity through innovative solutions, support and/or manage the BSO systems and tools within the Biorepository and Clinical Study Management teams and is responsible for the integrity of Denali's valuable clinical biospecimen collection, and associated data, to enable Denali's goals. This is achieved through oversight of BSO staff, hands-on work, collaboration with other functions and continuous improvement of BSO procedures and practices.
Job description
Key Accountabilities / Core Job 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
Qualifications/Skills
- 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
Requirements
- Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field
- 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
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.