Biosample Operations Associate

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

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics in South San Francisco, CA, is seeking a Biorepository Systems Manager to ensure sample integrity and compliant handling of clinical biospecimens within LIMS and related platforms.

You will oversee BSO staff, coordinate with Biorepository, Clinical Study Management, Data Management and Clinical Programming, and drive system improvements to support translational medicine programs.

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field with 5+ years translational medicine or clinical development experience.
• Experience with human biosample management, regulatory compliance and quality assurance in a clinical trials/drug development setting.
• Proficient in LIMS, advanced Excel, and interpreting Clinical Research Protocols.

Responsibilities

• Manage software containing clinical biospecimen data in collaboration with Biorepository, Clinical Study Management, Data Management and Clinical Programming.
• Maintain and improve BSO systems and tools, ensuring sample integrity and GCP/GDPR compliance.
• Design and build study collection plans for real-time import of samples into LIMS; coordinate with scientists, CROs and vendors.
• Oversee BSO vendors and mentor/train BSO staff; contribute to SOP creation and updates.
• Lead biomarker studies, collaborations and clinical study management projects; drive process improvements.

Skills

Biosample management

LIMS proficiency

Advanced Excel

Clinical protocol interpretation

Cross-functional collaboration

Regulatory compliance

Customer service orientation

Education

Bachelor's degree in Biochemistry/related field

Job description

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.We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.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.Key Accountabilities / Core Job ResponsibilitiesManagement of software containing clinical biospecimen data in close collaboration with Biorepository staff, Clinical Study Management, Data Management and Clinical ProgrammingResponsible for ongoing maintenance and improvements of BSO systems and tools, as necessaryEnsure sample integrity and maintain GCP and GDPR compliance for clinical trial samples through chain of custody, sample handling guidelines, and proper storage conditionsResponsible 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 vendorsMentor and train BSO staff, train relevant functional groups in BSO procedures, and participate in the creation and updating of BSO SOPsManagement of biomarker studies and collaborations, and support of clinical study management projectsLead process improvement projects to enable efficiency and innovation in BSO processesReview and approve Data Transfer Specifications, custom manifests, import files, and other sample data collection documentsQualifications/SkillsBachelor'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/trainingExperience with human biosample management, regulatory compliance, and quality assurance in a clinical trials/drug-development settingProficient in LIMS database entry, advanced Excel, and interpreting Clinical Research ProtocolsAbility to work effectively in a cross-functional team matrix environmentStrong customer-service focus with advanced planning and organizational skills; adapts quickly to shifting priorities and deadlinesSalary Range: $114,000.00 to $149,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careersThis compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.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.