Director, Bioassay Development

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.

We are seeking a Director, Bioassay Development to lead the Bioassay Development function within the Technical Operations Analytical & Formulation Development organization. This leader will provide strategic leadership to a team responsible for potency assay development and plate-based impurity assay development for complex protein biologics across a pipeline spanning early clinical development through commercial lifecycle management. The Director will be expected to balance commercial-ready assay rigor with phase-appropriate development for emerging programs, while building platform capabilities that can be leveraged across related protein biologic modalities.

In addition, the individual will be expected to have program-specific responsibilities driving assay development and potency strategy for one or more programs.

The role requires deep technical expertise in biologics potency methods, ligand-binding and cell-based assay platforms, method qualification and validation, assay transfer, regulatory filings, and GMP readiness. The Director will mentor a team, build functional capability, influence CMC strategy, and deliver bioassay methods that support the development and commercialization of innovative protein biologics for serious diseases.

This highly visible leadership role is expected to partner closely with Process Development, Quality Control, Quality Assurance, Regulatory CMC, Pharmaceutical Development, Translational Sciences, Program Teams, and external CRO/CDMO partners to ensure that bioassay strategies support clinical development, regulatory submissions, commercial readiness, and product lifecycle management.

Key Accountabilities / Core 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. Includes leading direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

• 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.

Qualifications/

Skills:

• 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,…