Principal Scientist, Translational Medicine
Denali Therapeutics
August 11, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Key Accountabilities / Core Job Responsibilities
- Lead complex, cross-functional, and external biomarker research projects within Translational Medicine
- Define biomarker strategies generating clinical evidence of target engagement, pathway engagement, and disease-biomarker modulation (including surrogate/intermediate endpoints supporting accelerated approval)
- Contribute biomarker strategy and data packages to BLAs and other regulatory submissions, including briefing documents and responses for health authority interactions
- Maintain deep expertise in rare disease biomarkers (e.g., lysosomal storage disorders) while expanding knowledge in adjacent CNS disorders
- Design and implement biomarker assays in clinically relevant biosamples
- Mentor junior scientists
- Analyze and interpret complex data; communicate results to scientific, clinical, and leadership audiences
- Maintain lab records consistent with good documentation practice
- Contribute to patent filings, diligence reports, publications, and regulatory documents
- Represent the organization at scientific conferences and through academic partnerships
Required Qualifications / Skills
- PhD in a relevant scientific discipline (biochemistry, neurobiology, molecular biology, pharmacology) with typically 10+ years post-training industry and/or academic experience
- Demonstrated expertise developing/executing/interpreting complex biomarker assays in clinical studies
- Experience contributing to regulatory submissions (BLA/NDA/IND), including biomarker-related sections and health authority interactions
- Record of high-quality publications and/or public presentations in rare disease/translational research/biomarkers
- Strong oral, written, and presentation communication skills
Preferred
- Rare/orphan disease drug development experience
- Experience supporting accelerated approval (biomarker qualification as surrogate/intermediate endpoint)
- Lysosomal storage disorders or rare pediatric genetic disease experience
- Experience with natural history studies and patient registries
- Direct experience in FDA/health authority meetings (e.g., Type B/C, briefing documents)
Application instructions
- Learn more at https://www.denalitherapeutics.com/careers
- Lead complex, cross-functional, and external biomarker research projects within Translational Medicine
- Define biomarker strategies generating clinical evidence of target engagement, pathway engagement, and disease-biomarker modulation (including surrogate/intermediate endpoints supporting accelerated approval)
- Contribute biomarker strategy and data packages to BLAs and other regulatory submissions, including briefing documents and responses for health authority interactions
- Maintain deep expertise in rare disease biomarkers (e.g., lysosomal storage disorders) while expanding knowledge in adjacent CNS disorders
- Design and implement biomarker assays in clinically relevant biosamples
- Mentor junior scientists
- Analyze and interpret complex data; communicate results to scientific, clinical, and leadership audiences
- Maintain lab records consistent with good documentation practice
- Contribute to patent filings, diligence reports, publications, and regulatory documents
- Represent the organization at scientific conferences and through academic partnerships
Required Qualifications / Skills
- PhD in a relevant scientific discipline (biochemistry, neurobiology, molecular biology, pharmacology) with typically 10+ years post-training industry and/or academic experience
- Demonstrated expertise developing/executing/interpreting complex biomarker assays in clinical studies
- Experience contributing to regulatory submissions (BLA/NDA/IND), including biomarker-related sections and health authority interactions
- Record of high-quality publications and/or public presentations in rare disease/translational research/biomarkers
- Strong oral, written, and presentation communication skills
Preferred
- Rare/orphan disease drug development experience
- Experience supporting accelerated approval (biomarker qualification as surrogate/intermediate endpoint)
- Lysosomal storage disorders or rare pediatric genetic disease experience
- Experience with natural history studies and patient registries
- Direct experience in FDA/health authority meetings (e.g., Type B/C, briefing documents)
Application instructions
- Learn more at https://www.denalitherapeutics.com/careers