Senior Principal Scientist, Translational Medicine

Denali Therapeutics•South San Francisco, CA

1d•$171,000 - $223,000

About The Position

Denali Therapeutics is seeking a Senior Principal Scientist in Translational Medicine to shape biomarker strategies for large-molecule programs in rare, genetically defined, and neurodegenerative diseases. The role partners with leaders across Discovery and Development to create biomarker-driven clinical development plans that support dose selection, proof-of-concept, and deep patient phenotyping. It applies drug-development and regulatory-science expertise to advance therapeutics through clinical development toward approval, while influencing program direction and strengthening the organization’s scientific reputation in biomarker science. The position leads complex biomarker research programs and cross-functional teams, directs biomarker assay design and implementation, and develops evidence of target engagement, pathway engagement, and disease-biomarker modulation. It also contributes to regulatory submissions and scientific communications, mentors scientists, and represents the organization in external scientific and academic settings.

Requirements

Typically requires a PhD in a relevant scientific discipline, such as biochemistry, neurobiology, molecular biology, or pharmacology, with 12+ years of industry and/or academic experience.
Expertise in developing, executing, and interpreting complex biomarker assays in a clinical study setting.
Experience contributing to regulatory submissions (e.g., BLA, NDA, IND), including biomarker sections and health authority interactions.
Record of high-quality publications and/or presentations in rare disease, translational research, or biomarkers.
Strong written, oral, and presentation skills for scientific and cross-functional audiences.

Nice To Haves

Experience in rare or orphan disease drug development, including lysosomal storage disorders, natural history studies, or patient registries.
Direct experience supporting an accelerated approval submission or FDA/health authority meetings (e.g., Type B/C meetings).

Responsibilities

Lead complex, cross-functional, and external biomarker research programs within Translational Medicine.
Lead cross-functional teams that deliver therapeutic project team objectives.
Define biomarker strategies that generate clinical evidence of target engagement, pathway engagement, and disease-biomarker modulation, including surrogate or intermediate endpoints that support accelerated approval.
Direct the design, qualification, and implementation of biomarker assays in clinically relevant biosamples.
Author biomarker strategies and data packages for BLAs and other regulatory submissions, including briefing documents and health authority responses.
Interpret complex data sets and communicate results to scientific, clinical, and leadership audiences.
Mentor and guide the scientific work of other scientists across lab and project teams.
Advance expertise in rare disease biomarkers, including lysosomal storage disorders, and integrate knowledge of adjacent disciplines such as CNS disorders.
Contribute to patent filings, diligence reports, publications, and regulatory documents.
Represent the organization at scientific conferences and in academic partnerships.