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

The Opportunity:

Denali Therapeutics is seeking a Bioanalytical Scientist to provide immunoassay expertise for non-GLP preclinical, GLP toxicology, and clinical studies supporting biotherapeutic discovery and development.  Working in close collaboration with colleagues in Development Sciences, Translational Sciences, Antibody Discovery, and Clinical Development, the candidate will devise and execute large molecule bioanalytical strategies for drug and ADA assays.  This individual will engage in development of assays for oligonucleotide-based biotherapeutics, in addition to other large molecule modalities.

Responsibilities:

• Perform quantitative bioanalytical immunoassay experiments to support non-regulated pharmacokinetic (PK) analyses of biotherapeutic drug candidates and evaluate anti-drug antibody (ADA) response.
• Develop oligonucleotide PK bioanalytical methods appropriate for regulated and clinical studies, and engage external CROs to support method transfer activities.
• Analyze, interpret, summarize and present large molecule and large molecule-based oligonucleotide conjugate DMPK/BA data to internal project teams. 
• Conduct assay development and assay transfer activities in collaboration with external CROs for assay validation in compliance with regulatory guidelines.
• Review and evaluate immunoassay bioanalytical results supplied by external CROs to ensure quality; Review GLP and clinical BA assay validation protocols and reports.
• Prepare bioanalytical method summaries to support preparation of study reports and relevant sections of regulatory IND/CTA filings.

• PhD in Biochemistry, Analytical Chemistry, Pharmacokinetics, or related scientific discipline, or BS/MS degree with 8+ years of biopharmaceutical industry experience.
• Demonstrated expertise in immunoassay/ligand binding assay techniques for biotherapeutic quantification in complex biological matrices.
• Command of regulatory guidelines for GLP and clinical bioanalysis of large molecules.
• Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex DMPK and BA data.
• Ability to work effectively and collaboratively on cross-functional projects teams.
• Excellent oral, presentation, and written communication skills.