Biomarker Operations Lead

Denali Therapeutics is seeking to recruit a Biomarker Operations (BMO) Lead, in support of the company's Development Operations (DevOps) team efforts. This individual will lead efforts to increase productivity through innovate solutions, support and/or manage the BMO systems and tools within the Biorepository and/or 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.

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 BMO 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.

• Management of Clinical trials (early and late stage) as the BMO study lead, responsible for design and execution of the biomarker, PK, PD and GX collection and analysis strategy. Including but not limited to protocol and ICF review, central lab setup and management, specialty lab setup and management, sample collection and reconciliation, sample analysis, and final storage.

• Manage, mentor, and train Junior staff, train relevant functional groups in BMO procedures, and participate in the creation and updating of BMO SOPs

• Management of Biomarker studies and collaborations, and support of Clinical study management projects

• Lead process improvement projects to enable efficiency and innovation in BMO processes

• Review and approve Data Transfer Specifications, custom manifests, import files, and other sample data collection documents

• Lead and/or support Development goals and initiatives in collaboration with other Development functional groups

Qualifications/Skills:

• Bachelor's degree in Biology, Medical Technology or related field

• 5+ years in Life Sciences, Computer Science, or related field

• Experience in Protection of Human Subjects in research

• Experience with regulatory compliance and quality assurance

• Working knowledge of clinical trials and/or drug development

• Excellent analytical and assessment skills; Technical knowledge to maintain electronic files, experience with LIMS database entry and advanced Microsoft excel skills

• Ability to review and interpret Clinical Research Protocols

• Entrepreneurial spirit with "can do" attitude, commitment to teamwork, and takes initiative

• Strong customer service focus; ability to work effectively in a cross-functional team matrix

• Seeks change & values innovation

• Advanced planning and organization skills, ability to meet tight deadlines and to quickly adapt to changing priorities.

Salary Range: $115,000.00 - $143,000.00. 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/careers

This 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.

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