Senior Principal Scientist, Translational Medicine

Partners with leaders across Discovery and Development to set biomarker strategy for large-molecule programs in rare, genetically defined, and neurodegenerative diseases. Shapes biomarker-driven clinical development plans that support dose selection, proof-of-concept, and deep patient phenotyping. Applies expert knowledge of drug development and regulatory science to move therapeutics through the clinic toward approval. Influences program direction and strengthens the organization’s scientific reputation in biomarker science. Key Accountabilities / Core Job 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 strategy 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 Qualifications / Skills Required • Typically requires a PhD in a relevant scientific discipline (e.g., biochemistry, neurobiology, molecular biology, 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 Preferred • 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) Salary Range: $171,000.00 to $223,000.00 . 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. 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.