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. Key Accountabilities / Core Job 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 Qualifications / Skills Required: • 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 Preferred: • 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) 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.