Job Description

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

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.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.