Senior Scientist-Clinical Bioanalysis

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.

• 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.

$161,000–$186,000 USD