Overview In this role you will drive development and qualification of translational and clinical biomarker assays for immune-mediated diseases, collaborating with cross-functional teams to implement bioanalysis strategy in support of clinical programs. You will act as a SME for assay development and data interpretation, and coordinate with central labs and external partners to ensure high-quality, timely data. This hands-on position combines immunology, translational science, and clinical operations in a fast-paced biotech setting. You will help shape biomarker strategies across phases of development with a focus on target engagement and pharmacodynamic readouts.
Responsibilities- Collaborate on late-stage development, qualification/validation, and implementation of translational and clinical biomarker assays for immune-mediated disease programs
- Serve as bioanalytical SME on cross-functional project teams (R&D, Clinical Development, Operations, Clinical Pharmacology, Regulatory, Biostatistics)
- Contribute to assay strategy and execution for measuring target engagement and pharmacodynamic responses (cytokines, chemokines, soluble receptors, immune cell markers)
- Support DMPK bioanalysis activities (PK, ADA, PD biomarkers) for biologics and novel modalities
- Provide SME support to central lab activities with regulatory alignment and phase-appropriate rigor (sample handling, feasibility, method transfer, validation, testing, data review)
- Collaborate with external CROs to ensure high-quality, on-time bioanalytical data
- Manage multiple bioanalytical projects with scientific rigor, operations, and timelines
- Maintain strong attention to regulatory compliance of bioanalytical work
Key requirements- 4+ years of direct industry experience for MS candidates; 2+ years for PhD candidates in biotech/biopharma/CRO settings supporting translational and clinical bioanalysis
- Hands-on experience with clinical central laboratories, including logistics of samples, assay execution, and data delivery
- Proficiency with bioanalytical platforms (ELISA, MSD/ECL, multiplex cytokine panels, flow cytometry, cell-based assays)
- Experience in immunology-focused biomarker assay development and clinical implementation
- Familiarity with PK/ADA assessments and DMPK bioanalysis
- Strong collaboration across multidisciplinary teams and external partners
- Excellent written and verbal communication skills
- Thrive in multi-project, fast-moving biotech environment
- Attention to regulatory compliance in bioanalysis
- Collaborative mindset
- Strong communication
- Attention to detail
- Ligand-binding assays (ELISA, MSD/ECL)
- Multiplex cytokine and protein panels
- Flow cytometry and immune cell phenotyping
