Director, Bioassay Development
Denali Therapeutics
August 22, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
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.
- Develop and implement phase-appropriate bioassay strategies across early development, clinical-stage advancement, late-stage readiness, and commercial lifecycle support.
- Drive robust, mechanism-of-action-based potency and plate-based impurity methods (e.g., enzymatic activity, receptor binding, cellular uptake, signaling, functional cell-based assays, reporter assays).
- Lead program-specific potency assay strategy and development (assay design, development, optimization, qualification, validation, transfer, and lifecycle management) aligned with MoA, CQAs, and regulatory expectations.
- Mentor and grow a high-performing team (goal setting, prioritization, feedback/coaching, training compliance).
- Build a culture of scientific excellence and pragmatic problem solving with rigorous experimental design and strong documentation.
- Partner cross-functionally (Process Development, QC/QA, Regulatory CMC, Translational Sciences, Program Leadership, external CRO/CDMO) to support control strategy, comparability, release/stability, and regulatory submissions.
- Establish and maintain assay control strategies (reference standards, critical reagents, system suitability, acceptance criteria, statistical models, trending, lifecycle monitoring).
- Provide technical leadership for troubleshooting, method transfer, regulatory support, and external lab oversight.
Qualifications/Skills
- Ph.D. in biochemistry/molecular biology/cell biology or related with 10+ years relevant biotech/pharma experience, including 8+ years people leadership (or M.S. with 14+ years).
- Deep expertise in bioassay development for protein biologics (ligand-binding and cell-based potency; plate-based impurity assays).
- Hands-on potency assay experience for complex biologics (recombinant proteins, enzymes, Fc-fusions, mAbs, bispecifics, receptor-targeted biologics, engineered therapeutics).
- Knowledge of assay statistics, DoE, reference standards, trending, troubleshooting.
- Experience with plate-based impurity assays and/or HCP ELISA, residual DNA, residual affinity ligands, process residuals.
- Strong understanding of CMC development (control strategy, CQAs, qualification/validation/transfer, comparability, stability/specifications).
- Experience across multiple biologics development stages (early/late clinical, regulatory filings, launch, post-approval lifecycle).
- GMP and regulatory requirements knowledge; experience authoring/reviewing regulatory submission content and responding to regulatory questions.
- Ability to lead through ambiguity, prioritize across programs, and make phase-appropriate decisions.
Benefits / Application Instructions
- Salary range: $208,000–$271,000; total rewards include 401(k), healthcare coverage, ESPP, and other benefits.
- Learn more and apply: https://www.denalitherapeutics.com/careers
- Lead the Bioassay Development sub-function within CMC Analytical Development, providing scientific/technical and people leadership for potency methods and plate-based impurity assays.
- Develop and implement phase-appropriate bioassay strategies across early development, clinical-stage advancement, late-stage readiness, and commercial lifecycle support.
- Drive robust, mechanism-of-action-based potency and plate-based impurity methods (e.g., enzymatic activity, receptor binding, cellular uptake, signaling, functional cell-based assays, reporter assays).
- Lead program-specific potency assay strategy and development (assay design, development, optimization, qualification, validation, transfer, and lifecycle management) aligned with MoA, CQAs, and regulatory expectations.
- Mentor and grow a high-performing team (goal setting, prioritization, feedback/coaching, training compliance).
- Build a culture of scientific excellence and pragmatic problem solving with rigorous experimental design and strong documentation.
- Partner cross-functionally (Process Development, QC/QA, Regulatory CMC, Translational Sciences, Program Leadership, external CRO/CDMO) to support control strategy, comparability, release/stability, and regulatory submissions.
- Establish and maintain assay control strategies (reference standards, critical reagents, system suitability, acceptance criteria, statistical models, trending, lifecycle monitoring).
- Provide technical leadership for troubleshooting, method transfer, regulatory support, and external lab oversight.
Qualifications/Skills
- Ph.D. in biochemistry/molecular biology/cell biology or related with 10+ years relevant biotech/pharma experience, including 8+ years people leadership (or M.S. with 14+ years).
- Deep expertise in bioassay development for protein biologics (ligand-binding and cell-based potency; plate-based impurity assays).
- Hands-on potency assay experience for complex biologics (recombinant proteins, enzymes, Fc-fusions, mAbs, bispecifics, receptor-targeted biologics, engineered therapeutics).
- Knowledge of assay statistics, DoE, reference standards, trending, troubleshooting.
- Experience with plate-based impurity assays and/or HCP ELISA, residual DNA, residual affinity ligands, process residuals.
- Strong understanding of CMC development (control strategy, CQAs, qualification/validation/transfer, comparability, stability/specifications).
- Experience across multiple biologics development stages (early/late clinical, regulatory filings, launch, post-approval lifecycle).
- GMP and regulatory requirements knowledge; experience authoring/reviewing regulatory submission content and responding to regulatory questions.
- Ability to lead through ambiguity, prioritize across programs, and make phase-appropriate decisions.
Benefits / Application Instructions
- Salary range: $208,000–$271,000; total rewards include 401(k), healthcare coverage, ESPP, and other benefits.
- Learn more and apply: https://www.denalitherapeutics.com/careers