Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company based in South San Francisco, California that is dedicated to defeating neurodegenerative diseases through rigorous therapeutic discovery and development. 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.
Denali is seeking a Scientist in support of large molecule bioanalysis efforts within the Bioanalysis group. You will work closely with Therapeutic Discovery, Development Sciences, Clinical Development, and Contract Research Organizations (CROs) to develop ligand binding assay methods for pharmacokinetic (PK) assessment of drug candidates, biomarkers, and anti-drug antibodies (ADA) from in vitro and in vivo samples.
- Perform quantitative bioanalytical immunoassay experiments in various biological matrices to support non-regulated pharmacokinetic (PK) analyses of biotherapeutic drug candidates and evaluate anti-drug antibody (ADA) responses.
- Develop PK, ADA, and biomarker bioanalytical methods appropriate for regulated and clinical studies, and engage and manage external CROs on method optimization, assay transfer, qualification/validation, and sample analysis to ensure delivery of bioanalytical results within project timelines.
- Analyze, interpret, summarize and present large molecule and large molecule-based PK and ADA data to internal and external scientists and project teams.
- 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 and contribute to clinical protocol development.
- PhD in Biochemistry, Analytical Chemistry, Pharmacokinetics, or related scientific discipline, with 0-3- years of relevant experience
- OR Master's degree and 3+ years of biotech/pharmaceutical or CRO experience in LBA bioanalysis
- OR Bachelor's degree and 6+ years of biotech/pharmaceutical or CRO experience in LBA bioanalysis
- Demonstrated expertise in immunoassay/ligand binding assay techniques for biotherapeutic quantification in complex biological matrices.
- Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex DMPK and BA data.
- Demonstrated ability to work effectively and collaboratively with other scientists on cross-
functional Project Teams
- Excellent oral presentation and written communication skills
- Working knowledge of quantitative bioanalytical principles, with GLP/GCP regulated assay
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.
Salary Range: $121,000 - $153,000. 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.