Senior Scientist-Clinical Bioanalysis
Kiniksa Pharmaceuticals
August 22, 2026
On-site
Lexington, MA
Clinical Research and Development
Responsibilities:
- Develop, qualify/validate, and implement translational and clinical biomarker assays supporting immune-mediated disease programs.
- Serve as a bioanalytical SME on cross-functional teams (Research, Clinical Development, Operations, Clinical Pharmacology, Regulatory, Biostatistics).
- Define and execute assay development strategy for target engagement and pharmacodynamic responses (e.g., cytokines, chemokines, soluble receptors, immune cell markers).
- Support DMPK bioanalysis for biologics and novel modalities, including PK, ADA, and PD biomarker integration.
- Provide SME support to central lab activities (as applicable): sample collection/handling, assay feasibility and operational readiness, method transfer/validation/clinical testing, and data review/query resolution/issue management.
- Partner with external CROs to ensure high-quality, on-time bioanalytical data.
- Manage multiple bioanalytical projects while maintaining rigor, excellence, and timelines.
Standout Skills For Impact:
- Immunology-focused biomarker assay development and clinical implementation.
- DMPK bioanalysis knowledge (PK, ADA).
- Regulatory expectations and industry best practices for bioanalytical assays and clinical lab operations.
Qualifications And Experience:
- MS or PhD in Analytical biochemistry, Cell biology, Immunology, or related life science (PhD preferred).
- 4+ years (MS) or 2+ years (PhD) direct industry experience in biotech/biopharma and/or CRO settings supporting translational/clinical bioanalysis.
- Experience with clinical central laboratories (sample logistics, assay execution, data delivery).
- Hands-on experience with immune disease bioanalytical platforms: ligand-binding assays (e.g., ELISA, MSD/ECL), multiplex cytokine/protein panels, flow cytometry/immune phenotyping, and cell-based functional assays.
- Experience partnering across multidisciplinary teams and managing external partners.
- Ability to thrive in a fast-moving, multi-project environment.
- Strong attention to regulatory-compliance details; strong written/verbal communication.
Pay Range:
- $161,000 - $186,000 USD
- Develop, qualify/validate, and implement translational and clinical biomarker assays supporting immune-mediated disease programs.
- Serve as a bioanalytical SME on cross-functional teams (Research, Clinical Development, Operations, Clinical Pharmacology, Regulatory, Biostatistics).
- Define and execute assay development strategy for target engagement and pharmacodynamic responses (e.g., cytokines, chemokines, soluble receptors, immune cell markers).
- Support DMPK bioanalysis for biologics and novel modalities, including PK, ADA, and PD biomarker integration.
- Provide SME support to central lab activities (as applicable): sample collection/handling, assay feasibility and operational readiness, method transfer/validation/clinical testing, and data review/query resolution/issue management.
- Partner with external CROs to ensure high-quality, on-time bioanalytical data.
- Manage multiple bioanalytical projects while maintaining rigor, excellence, and timelines.
Standout Skills For Impact:
- Immunology-focused biomarker assay development and clinical implementation.
- DMPK bioanalysis knowledge (PK, ADA).
- Regulatory expectations and industry best practices for bioanalytical assays and clinical lab operations.
Qualifications And Experience:
- MS or PhD in Analytical biochemistry, Cell biology, Immunology, or related life science (PhD preferred).
- 4+ years (MS) or 2+ years (PhD) direct industry experience in biotech/biopharma and/or CRO settings supporting translational/clinical bioanalysis.
- Experience with clinical central laboratories (sample logistics, assay execution, data delivery).
- Hands-on experience with immune disease bioanalytical platforms: ligand-binding assays (e.g., ELISA, MSD/ECL), multiplex cytokine/protein panels, flow cytometry/immune phenotyping, and cell-based functional assays.
- Experience partnering across multidisciplinary teams and managing external partners.
- Ability to thrive in a fast-moving, multi-project environment.
- Strong attention to regulatory-compliance details; strong written/verbal communication.
Pay Range:
- $161,000 - $186,000 USD