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About the Role

Denali Therapeutics is seeking a Director, Bioassay Development to lead the Bioassay Development function. This leader will provide strategic leadership for potency and impurity assay development for complex protein biologics, balancing rigor with phase-appropriate development and building platform capabilities. The role involves program-specific responsibilities driving assay development and potency strategy.

Responsibilities

Lead the Bioassay Development sub-function within CMC Analytical Development, providing scientific, technical, and people leadership for potency methods and plate-based impurity assays supporting protein biologics across the development lifecycle.
Develop and implement phase-appropriate bioassay strategies for programs spanning early development, clinical-stage advancement, late-stage readiness, and commercial lifecycle support, ensuring methods are fit for purpose at each stage.
Drive development of robust, mechanism-of-action-based potency and plate-based impurity methods for complex biologics, including enzymatic activity, receptor binding, cellular uptake, signaling, functional cell-based assays, reporter assays, and other relevant biological readouts.
Lead program-specific potency assay strategy and development, including assay design, development, optimization, qualification, validation, transfer, and lifecycle management in alignment with product mechanism of action, critical quality attributes, and regulatory expectations.
Mentor, develop, and grow a high-performing team of scientists, providing technical guidance, career development, prioritization, feedback, and coaching.
Build a culture of scientific excellence, collaboration, accountability, and pragmatic problem solving, ensuring the team applies rigorous experimental design, sound data interpretation, strong documentation practices, and phase-appropriate decision-making.
Partner cross-functionally with Process Development, QC, QA, Regulatory CMC, Translational Sciences, Program Leadership, and external partners to ensure bioassay strategies support process understanding, control strategy, comparability, release, stability, and regulatory submissions.
Establish and maintain assay control strategies, including reference standards, critical reagents, system suitability criteria, assay acceptance criteria, statistical models, trending approaches, and lifecycle monitoring.
Provide technical leadership for assay troubleshooting, method transfer, regulatory support, and external laboratory oversight, ensuring bioassay methods are robust, reproducible, compliant, and capable of supporting key CMC and program milestones.

Requirements

Typically requires a Ph.D. in biochemistry, molecular biology, cell biology, or a related discipline with 10+ years of directly relevant biotechnology or pharmaceutical industry, including 8+ years in a people leadership role (or M.S. with 14+ years of relevant experience).
Deep technical expertise in bioassay development for protein biologics, including ligand-binding and cell-based potency methods and plate-based impurity assay formats.
Hands-on experience developing potency assays for complex biologics such as recombinant proteins, enzymes, Fc-fusion proteins, monoclonal antibodies, bispecifics, receptor-targeted biologics, or other engineered protein therapeutics.
Strong knowledge of assay statistics, design of experiments, reference standard strategy, assay trending, and troubleshooting of complex biological assays.
Demonstrated experience with plate-based impurity assays, host cell protein ELISA, residual DNA, residual affinity ligands, process residuals, or product/process-specific impurities.
Strong understanding of CMC development for biologics, including analytical control strategy, critical quality attributes, reference standards, method qualification, validation, transfer, comparability, stability, and specification setting.
Experience supporting biologics programs across multiple development stages, ideally including early clinical development, late-stage development, regulatory filing, commercial launch, or post-approval lifecycle management.
Prior experience managing experienced scientists and leading a functional or sub-functional team within Analytical Development, CMC, Technical Operations, or Quality Control.
Strong working knowledge of GMP expectations and regulatory requirements for biologics analytical methods.
Experience authoring or reviewing regulatory submission content and responding to regulatory questions related to analytical methods.
Demonstrated ability to lead through ambiguity, prioritize across multiple programs, and make phase-appropriate technical decisions in a fast-moving biotech environment.

Skills

Bioassay development
Potency assay development
Plate-based impurity assay development
Protein biologics
Ligand-binding assays
Cell-based assays
Method qualification
Method validation
Assay transfer
Regulatory filings
GMP readiness
Assay statistics
Design of experiments
Reference standard strategy
Assay trending
Troubleshooting complex biological assays
Host cell protein ELISA
Residual DNA
Residual affinity ligands
Process residuals
Product/process-specific impurities
Analytical control strategy
Critical quality attributes
Method qualification
Method validation
Assay transfer
Comparability
Stability
Specification setting
GMP expectations
Regulatory requirements
Regulatory submission content authoring/review
Responding to regulatory questions

Experience Level

10+ years of directly relevant biotechnology or pharmaceutical industry experience
8+ years in a people leadership role
M.S. with 14+ years of relevant experience

Education Level

Ph.D. in biochemistry, molecular biology, cell biology, or a related discipline
M.S.

Salary/Compensations

$208,000.00 to $271,000.00

Benefits

401k
Healthcare coverage
ESPP
Broad range of other benefits

About the Company

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.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

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.