Senior Scientist, Biomarkers

Responsibilities

• Lead fluid biomarker strategy for clinical programs, ensuring alignment with clinical objectives, regulatory expectations, and translational hypotheses.
• Design and oversee development, qualification, and validation of biomarker assays at CROs and external laboratory partners.
• Provide scientific oversight for assay selection, fit-for-purpose validation, and performance monitoring.
• Contribute to clinical protocol development, statistical analysis plans, and regulatory documents (e.g., INDs, briefing books).
• Direct development and validation/qualification of blood-based and other fluid biomarker assays (e.g., protein, enzymatic, molecular assays).
• Ensure assays are developed under appropriate regulatory frameworks (GLP/GCLP/CLIA as applicable).
• Evaluate assay performance characteristics including sensitivity, specificity, precision, robustness, and stability.
• Troubleshoot assay performance issues and implement corrective actions.
• Partner closely with clinical operations and sample management teams to ensure seamless biomarker sample collection, handling, and analysis.
• Collaborate with peers responsible for immunogenicity and PK assays to ensure integrated PK/PD and biomarker analysis.
• Oversee data generation timelines, budgets, and vendor performance.
• Lead scientific review and interpretation of biomarker data to support internal decision-making.
• Work closely with Clinical Development, Regulatory, Biostatistics, CMC, and Research teams.
• Contribute to cross-program biomarker governance and best practices.
• Represent the Biomarkers group in cross-functional team meetings and external vendor discussions.
• Perform and/or oversee robust statistical and scientific analysis of biomarker data.
• Integrate biomarker findings with clinical endpoints and PK data.
• Prepare high-quality summaries and presentations for internal governance and external regulatory interactions.

Qualifications

• Required: PhD in Immunology, Molecular Biology, Biochemistry, Translational Medicine, or related discipline with 4+ years of industry experience; or MS with 8+ years of relevant industry experience.
• Required: Demonstrated experience supporting clinical-stage programs.
• Required: Strong experience in assay development and fit-for-purpose validation (protein, enzymatic, or molecular assays).
• Required: Hands-on experience managing assay development at CROs and external laboratories.
• Required: Deep understanding of GCLP/GLP principles and regulatory expectations for clinical biomarker assays.
• Required: Experience with blood-based biomarker assays required.
• Preferred: Familiarity with PK/PD concepts and translational biomarker strategy.
• Required: Strong data analysis skills and ability to interpret complex biomarker datasets.
• Preferred: Experience contributing to regulatory submissions (INDs, briefing documents, clinical study reports).
• Required: Ability to critically evaluate assay performance and scientific rigor.
• Required: Demonstrated ability to manage external vendors and timelines.
• Required: Strong time and resource management skills.
• Required: Ability to operate independently while thriving in a collaborative, cross-functional environment.
• Required: Excellent written and verbal communication skills.
• Preferred: Experience in rare disease programs.
• Preferred: Experience with genetic medicine or gene editing platforms.
• Preferred: Experience supporting first-in-human studies.
• Preferred: Exposure to multiplexed, LC/MS-based, or advanced molecular biomarker platforms.

Education

• PhD in Immunology, Molecular Biology, Biochemistry, Translational Medicine, or related discipline with 4+ years of industry experience; or MS with 8+ years of relevant industry experience.
• Demonstrated experience supporting clinical-stage programs.