Senior Scientist-Clinical Bioanalysis
Kiniksa Pharmaceuticals
10 days ago
On-site
Lexington, MA
Clinical Research and Development
Senior Scientist/Manager, Clinical Bioanalysis (Lexington, MA — onsite 5 days/week)
Responsibilities:
- Collaborate on late-stage development, qualification/validation, and implementation of translational and clinical biomarker assays for immune-mediated disease programs.
- Serve as a bioanalytical SME on cross-functional teams (Early Research, Clinical Development & Operations, Clinical Pharmacology, Regulatory, Biostatistics).
- Lead assay development strategy/execution for target engagement and pharmacodynamic responses (e.g., cytokines, chemokines, soluble receptors, immune cell markers).
- Support DMPK bioanalysis including PK, ADA, and PD biomarker integration for biologics and novel therapeutic modalities.
- Provide SME support to central lab activities: sample collection/handling, assay feasibility and operational readiness, method transfer/validation and clinical sample testing, data review/query resolution/issue management.
- Partner with external CROs to ensure high-quality, on-time bioanalytical data delivery.
- Manage multiple bioanalytical projects while maintaining rigor, operational excellence, and timelines.
Qualifications:
- MS or PhD in Analytical Biochemistry, Cell Biology, Immunology, or related life science; PhD preferred.
- Industry experience: 4+ years (MS) or 2+ years (PhD) in biotech/biopharma and/or CRO supporting translational/clinical bioanalysis.
- Strong immunology-focused biomarker assay development and clinical implementation experience.
- Experience with clinical central labs (sample logistics, assay execution, data delivery).
- Hands-on experience with immune-disease bioanalytical platforms: ELISA/MSD/ECL ligand-binding; multiplex cytokine/protein panels; flow cytometry/immune phenotyping; cell-based functional assays.
- Knowledge of DMPK bioanalysis (PK, ADA).
- Familiarity with regulatory expectations/best practices for bioanalytical assays and clinical lab operations.
- Proven cross-functional collaboration and external partner management.
- Strong communication skills and attention to regulatory detail.
Pay Range:
- $161,000–$186,000 USD
Responsibilities:
- Collaborate on late-stage development, qualification/validation, and implementation of translational and clinical biomarker assays for immune-mediated disease programs.
- Serve as a bioanalytical SME on cross-functional teams (Early Research, Clinical Development & Operations, Clinical Pharmacology, Regulatory, Biostatistics).
- Lead assay development strategy/execution for target engagement and pharmacodynamic responses (e.g., cytokines, chemokines, soluble receptors, immune cell markers).
- Support DMPK bioanalysis including PK, ADA, and PD biomarker integration for biologics and novel therapeutic modalities.
- Provide SME support to central lab activities: sample collection/handling, assay feasibility and operational readiness, method transfer/validation and clinical sample testing, data review/query resolution/issue management.
- Partner with external CROs to ensure high-quality, on-time bioanalytical data delivery.
- Manage multiple bioanalytical projects while maintaining rigor, operational excellence, and timelines.
Qualifications:
- MS or PhD in Analytical Biochemistry, Cell Biology, Immunology, or related life science; PhD preferred.
- Industry experience: 4+ years (MS) or 2+ years (PhD) in biotech/biopharma and/or CRO supporting translational/clinical bioanalysis.
- Strong immunology-focused biomarker assay development and clinical implementation experience.
- Experience with clinical central labs (sample logistics, assay execution, data delivery).
- Hands-on experience with immune-disease bioanalytical platforms: ELISA/MSD/ECL ligand-binding; multiplex cytokine/protein panels; flow cytometry/immune phenotyping; cell-based functional assays.
- Knowledge of DMPK bioanalysis (PK, ADA).
- Familiarity with regulatory expectations/best practices for bioanalytical assays and clinical lab operations.
- Proven cross-functional collaboration and external partner management.
- Strong communication skills and attention to regulatory detail.
Pay Range:
- $161,000–$186,000 USD