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About the Role
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.
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
- 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
Requirements
- 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
Skills
- LIMS database entry
- Advanced Excel
- Interpreting Clinical Research Protocols
- Cross-functional team collaboration
- Customer-service focus
- Advanced planning
- Organizational skills
- Adaptability to shifting priorities and deadlines
Location
- Remote
Work Type
- Full-time
Experience Level
- Minimum of 5 years of experience
Education Level
- Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field
Salary/Compensations
- $114,000.00 to $149,000.00
Benefits
- 401k
- Healthcare coverage
- ESPP
About the Company
- Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform.
- With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
- Learn more at https://www.denalitherapeutics.com/careers
Equal Opportunity
- Denali is committed to its core company value of unity by creating a diverse and inclusive environment.
- We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.