Biomarker Research Scientist

Denali Therapeutics, South San Francisco, USA

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

Denali Therapeutics is seeking to recruit an Biomarker Research Scientist in Biomarker Operations to support the transfer of biomarker assays into clinical trials. This scientist will enable the collection of high-quality samples from a large number of clinical sites through optimization and standardization of pre-analytical variables. This will include testing analyte stability under variable collection, processing, shipping and storage conditions. Will also develop innovative approaches to allow the collection of challenging specimens for analysis of new biomarkers.   Will be responsible for training sites in new procedures and for developing quality assurance processes. This will be achieved by close collaboration with multifunctional teams.

This is a laboratory-based position that offers opportunities to expand technical skills and learn outside of the laboratory through cross-functional development team meetings and coaching.

Responsibilities:

• Work with Biomarker and Bioanalytic Scientists to support the transition of biomarker assays into clinical trials through optimizing, standardizing and documenting pre-analytical sample processing conditions.
• Standardize and optimize new specimen collection and processing procedures
• Author Standard Operating Procedures (SOPs)
• Train and support clinical sites to perform optimized specimen processing procedures
• Oversee quality assurance, to qualify and monitor specimen collection at clinical sites
• Work closely with Biospecimen Management Group to document specimen collection and ensure collection of high-quality specimen data
• Work closely with Clinical Operations and external CRO to support the implementation of clinical trails
• Assist with the management of CROs performing outsourced clinical assays

Requirements:

• BS in a relevant area and 5+ years of experience in processing human samples for research or clinical assays
• OSHA Laboratory or equivalent safety training
• Understanding of GLP
• Experience in writing Standard Operating Procedures
• Experience in immunology assay platforms such as flow cytometry and Immunoassays is an advantage
• Proven ability to work as part of a team
• Excellent written and communication skills
• Proficient in word, excel, powerpoint and basic statistical analysis and graphing software
• Experience with LIMS an advantage
• This position requires on-site work at Denali and compliance with COVID-19 safety protocols