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, 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.

Salary Range: $208,000.00 to $271,000.00 .  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.