Manager, Biosample Operations
About The Position
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This individual will manage the biospecimen lifecycle for Denali’s clinical programs through collaboration with Clinical Operations, Data Management, Translational Medicine, Pharmacology scientists, and external vendors that support Denali’s clinical studies.
Requirements
- Bachelor’s degree in Biology, Immunology, Neuroscience, Medical Technology, or related field is recommended, OR 5 years of experience in Translational Medicine or Clinical Development, or related field / training
- Working knowledge of biosample management for clinical trials.
- Familiarity with relevant FDA & ICH/GCP regulations
- Ability to lead effectively in a cross-functional team matrix environment
- Entrepreneurial spirit with “can do” attitude and commitment to work as part of a team
- Seeks change & values innovation
- Advanced planning and organization skills and excellent analytical skills
Nice To Haves
- Technical know how to create tools to solve operational challenges and improve workflows
- Ability to review and interpret clinical research protocols
Responsibilities
- Development of biospecimen lifecycle strategies through close collaboration with Biomarker Operations study leads and Clinical Study team
- Ensure program level consistency of biospecimen collection, processing, storage, and analysis
- Supervise, support and train Biomarker Operations clinical study leads
- Contribute to development of study protocols, ICFs and other relevant study documents
- Collaborate with Clinical Operations, Procurement and Quality in the selection and management of central laboratories and specialty bioanalysis labs
- Manage the creation of complex sample management plans and laboratory documents that ensure the proper collection and storage of samples at clinical sites
- Create systems and tools to manage sample analysis plans and enable study leads to deliver samples to appropriate analysis vendors on time
- Facilitate biomarker vendor interactions with Data Management to ensure consistency in the transmission of sample metadata for accurate identification of analyzed samples
- Design LIMS study collection plans to allow real-time import of incoming samples into Biosample Management’s LIMS Database. This requires coordination with scientists, CROs and vendors and ability to interpret clinical study protocols.
- Participate in cross-functional projects and working groups.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
