Senior Principal Scientist, Translational Medicine

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using its TransportVehicle platform.

The role leads complex biomarker research programs and cross-functional teams to generate clinical evidence of target engagement and disease biomarkers. You will design and qualify biomarker assays for clinical samples, author strategy documents for regulatory submissions, mentor scientists, and advance expertise in rare

Qualifications

• PhD in a relevant scientific discipline with 12+ years of industry/academic experience.
• Expertise in developing, executing, and interpreting complex biomarker assays in a clinical study setting.
• Experience contributing to regulatory submissions (BLA, NDA, IND) and health authority interactions.
• Strong record of publications/presentations in rare disease, translational research, or biomarkers.

Responsibilities

• Lead cross-functional and external biomarker research programs.
• Define strategies to show target engagement and disease-biomarker modulation.
• Direct design and qualification of biomarker assays in clinically relevant samples.
• Prepare biomarker strategy and data packages for regulatory submissions and responses.
• Mentor other scientists and represent the organization at conferences.

Skills

Biomarker research

Regulatory submissions

Scientific communication

Mentoring

Orphan disease experience

Biomarker assay design

Cross-functional leadership

Education

PhD in relevant discipline

Job description

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. 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.

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.

“Life at Denali” is a living reflection of our values: trust, unity, grit and growth.

These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.