Senior Scientist-Clinical Bioanalysis

Responsibilities (including, but not limited to)

• Collaborate with internal Research development, perform the late-stage development, qualification/validation, and implementation of translational and clinical biomarker assays supporting immune-mediated disease programs.
• Participate as a bioanalytical subject matter expert on cross-functional project teams, working closely with internal early Research, Clinical Development and Operations, Clinical Pharmacology, Regulatory, Biostatistics.
• Contribute as a SME to bioanalytical assays development strategy and execution for measuring target engagement, and pharmacodynamic responses (e.g., cytokines, chemokines, soluble receptors, immune cell markers) and more associated with the immune biology of the clinical studies.
• Support DMPK bioanalysis activities, including PK, ADA, and PD biomarker integration, for biologics and novel therapeutic modalities.
• Partner with clinical development, operations to provide SME support to central lab activities aligned with current regulatory guidance and industry best practices while remaining fit-for-purpose for each phase of development, including but not limited to activities such as:
• Sample collection and handling strategies
• Assay feasibility assessments and operational readiness
• Method transfer, validation, and clinical sample testing
• Data review, query resolution, and issue management
• Collaborate with external CRO partnerships to ensure high-quality, on-time delivery of bioanalytical data.
• Manage multiple bioanalytical projects simultaneously while maintaining scientific rigor, operational excellence, and timelines assigned to the role.

Standout Skills for Impact

• Strong background in immunology-focused biomarker assay development and clinical implementation.
• Working knowledge of DMPK bioanalysis, including PK and ADA assessments.
• Familiarity with regulatory expectations and industry best practices for bioanalytical assays and clinical laboratory operations.

Qualifications and Experience

• MS or PhD in Analytical biochemistry, Cell biology, Immunology, or a related life science discipline. PhD in the related fields is preferred.
• Requiring respective 4+ years for MS and 2+ years for PhD candidates direct industry experience in biotech, biopharmaceutical and/or CRO settings supporting translational and clinical bioanalysis.
• Experience working with clinical central laboratories, including coordination of sample logistics, assay execution, and data delivery for clinical studies.
• Hands-on experience with bioanalytical platforms commonly used in immune disease research, such as (but not limited):
• Ligand-binding assays (ELISA, MSD/ECL, other novel platforms)
• Multiplex cytokine and protein panels by various technology platforms
• Flow cytometry and immune cell phenotyping assays
• Cell-based functional assays
• Proven experience collaborating across multidisciplinary teams and managing external partners.
• Ability to thrive in a multi-project, fast-moving biotech environment.
• Strong attention the bioanalytical details for regulatory compliance.
• Strong written and verbal communication skills with the ability to clearly convey complex scientific and operational information.

Additional information

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range $161,000—$186,000 USD

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