Associate Director, Bioanalysis

Location: South San Francisco
Posted on: June 23, 2025

Job Description:

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. The Associate Director in Bioanalytical Sciences oversees development, validation, and implementation of bioanalytical methods to support drug discovery and development. The incumbent ensures accurate analysis of biological samples, leads scientific teams, and collaborates cross-functionally to ensure regulatory compliance and timely delivery of project goals. Key Accountabilities/Core Job Responsibilities: Lead efforts of establishing ligand-binding and cell-based methods supporting discovery and development of novel therapeutics, including measurement of biomarkers, drug concentration, and anti-drug antibodies. Devise innovative bioanalytical strategies for advancing drug development portfolio. Manage bioanalytical CROs for method optimization, assay transfer, qualification/validation, sample testing, and delivery of results within project timelines. Write, review, and finalize bioanalytical study reports that adhere to global regulatory guidelines for IND/CTA/BLA/NDA filings. Analyze, interpret, and present data to project teams and health authorities; prepare regulatory documents for submission, eg, summary documents and briefing packages. Contribute to budget and resource planning. Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Qualifications/Skills: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific discipline with 7 years of biotechnology or pharmaceutical industry experience overall, including 5 years in roles with people management responsibilities (alternatively an MS with 8 years or a BS with 10 years of industry experience) Expertise in design, development, and phase-appropriate qualification/validation of ligand-binding and cell-based assays for clinical and regulated studies in compliance with regulatory guidance (FDA, EMA, and ICH). Proficient in bioanalysis processes, tools, and instrumentation for drug discovery and development. Practical knowledge of immunogenicity assessment of biologics. Excellent critical thinking, communication, and collaboration skills, with experience working cross-functionally and with CROs. Salary Range: $167,000.00 to $211,000.00. 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. 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.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. 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.

Keywords: , North Highlands , Associate Director, Bioanalysis, Science, Research & Development , South San Francisco, California