Principal Scientist, Translational Medicine

About the role

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

Required Qualifications / Skills

• 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

• 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)

Pay

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.

Benefits

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