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About the Role
Denali Therapeutics is seeking a candidate to pioneer a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. This role is crucial in 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.
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.
Requirements
- 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.
- 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).
Skills
- Biomarker strategy
- Biomarker assay development
- Clinical development plans
- Regulatory science
- Biomarker research
- Cross-functional team leadership
- Biomarker assay design
- Biomarker assay qualification
- Biomarker assay implementation
- Regulatory submissions
- Data interpretation
- Scientific communication
- Mentoring
- Rare disease biomarkers
- Lysosomal storage disorders
- CNS disorders
- Patent filings
- Diligence reports
- Publications
- Regulatory documents
- Scientific conferences
- Academic partnerships
- Written communication
- Oral communication
- Presentation skills
Experience Level
- 12+ years of industry and/or academic experience
Education Level
- PhD in a relevant scientific discipline (e.g., biochemistry, neurobiology, molecular biology, pharmacology)
Salary/Compensations
- $171,000.00 to $223,000.00
Benefits
- 401k
- Healthcare coverage
- ESPP
- Broad range of other benefits
About the Company
- 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.
Equal Opportunity
- 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.