Principal Scientist, Translational Medicine

Denali Therapeutics•South San Francisco, CA

4d•$171,000 - $223,000

About The Position

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. This role partners with experts across Discovery and Development to build biomarker strategies that enable biomarker-driven clinical development plans supporting dose selection, biomarker proof-of-concept, and deep patient phenotyping in rare, genetically defined, and/or neurodegenerative diseases. It brings broad drug development and regulatory expertise together with biomarker strategy leadership to advance large-molecule therapeutics through the clinical pipeline and approval.

Requirements

PhD in a relevant scientific discipline (e.g., biochemistry, neurobiology, molecular biology, pharmacology) with typically 10+ years of post-training industry and/or academic experience
Demonstrated expertise in developing, executing, and interpreting complex biomarker assays in a clinical study setting
Experience contributing to regulatory submissions (e.g., BLA, NDA, IND), particularly biomarker-related sections and health authority interactions
Record of high-quality publications and/or public presentations in rare disease, translational research, or biomarkers
Strong oral, written, and presentation communication skills across scientific and cross-functional audiences

Nice To Haves

Experience in rare/orphan disease drug development
Direct experience supporting an accelerated approval submission, including biomarker qualification as a surrogate or intermediate clinical endpoint
Experience with lysosomal storage disorders or other rare pediatric genetic diseases
Experience with natural history studies and patient registries in rare disease settings
Direct experience in FDA/health authority meetings (e.g., Type B/C meetings, briefing documents)

Responsibilities

Leads complex, cross-functional, and external biomarker research projects within Translational Medicine
Defines biomarker strategies that generate clinical evidence of target engagement, pathway engagement, and disease-biomarker modulation, including biomarkers positioned as surrogate or intermediate clinical endpoints in support of accelerated approval
Contributes biomarker strategy and data packages to BLAs and other regulatory submissions, including briefing documents and responses for health authority interactions
Maintains deep scientific expertise in rare disease biomarkers such as lysosomal storage disorders while expanding knowledge of adjacent disciplines, including CNS disorders
Designs and implements biomarker assays in clinically relevant biosamples
Mentors junior scientists across lab and project-team settings
Analyzes and interprets complex data sets, communicating results clearly across scientific, clinical, and leadership audiences
Maintains lab records consistent with good documentation practice
Contributes to patent filings, diligence reports, publications, and regulatory documents
Represents the organization at scientific conferences and through academic partnerships