Associate Scientist, Bioanalytical

Associate Scientist, Bioanalytical DMPK

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 Associate Scientist to provide immunoassay expertise for preclinical, GLP toxicology, and clinical studies supporting protein therapeutic discovery and development. Working in close collaboration with colleagues in Discovery, Development Sciences, and Clinical Development, the candidate will devise and execute large molecule bioanalytical strategies for drug and ADA assays. This individual will also work closely with scientists in Discovery Biology and Translational Biomarkers to lend large molecule and biomarker bioanalytical expertise to discovery programs conducting in vivo PK/PD studies. S/he will be responsible for contracting and managing GLP and clinical large molecule assay development and validation activities and will write, edit, and finalize appropriate sections of regulatory filings and play a key role in interactions with global health authorities.

Responsibilities:

• Devise regulated and clinical bioanalytical strategies for large molecule drug candidates, and lead efforts conducting PK, ADA, and biomarker assays internally and working with CROs.
• Contract, oversee, and manage outsourced non-GLP, GLP, and clinical BA assay development and validation in compliance with appropriate regulatory and compliance guidelines.
• Review, edit, and finalize GLP and clinical BA assay validation protocols, and reports, ensuring that documents meet global regulatory and compliance requirements and project timelines.
• Review and evaluate immunoassay/ligand binding assay bioanalytical results supplied by external or internal sources to ensure quality; provide troubleshooting support when needed.
• Support internal large molecule Discovery Project Teams during lead optimization; contribute PK and ADA expertise to generate key data to enable team success.
• Analyze, interpret, summarize and present large molecule DMPK/BA data to internal project teams, senior management, and to global health authorities.
• Write, edit, and finalize (nonclinical and clinical) DMPK/BA sections of IND/CTA filings.
• Contribute to protocol development for clinical studies; analyze, interpret, and summarize clinical DMPK/BA data.

Requirements:

• PhD in Biochemistry, Analytical Chemistry, Pharmacokinetics, or related scientific discipline, or BS/MS degree with 3-6 years of biopharmaceutical industry drug development experience.
• Extensive expertise in immunoassay/ligand binding assay techniques for biotherapeutic quantification in complex biological matrices; and experience developing, performing, and managing ADA analyses.
• Command of regulatory guidelines for GLP and clinical bioanalysis of large molecules, with a record of successful assay development and validation for GLP toxicology studies supporting IND/ CTA filings and subsequent clinical trials.
• Working knowledge of large molecule pharmacokinetic and tissue biodistribution concepts.
• Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex DMPK and BA data.
• Experience with outsourcing and vendor management overseeing all aspects of outsourced GLP and clinical bioanalytical method development, validation, and sample analysis activities.
• Ability to work effectively and collaboratively on cross-functional projects teams.
• Excellent oral, presentation, and written communication skills.
• Ability to travel to manage CRO collaborations.