Principal Scientist, Biomarker Bioanalytical Sciences

About This Role

The Biomarkers and Systems Biology group is seeking a highly motivated Principal Scientist to contribute to the development and implementation of biomarker and bioanalytical strategies supporting discovery, translational, and clinical-stage programs. The successful candidate will serve as a Bioanalytical Lead for assigned programs, providing scientific leadership for assay development, analytical validation, CRO oversight for sample analysis and data interpretation to support critical development decisions.

This role will partner closely with various internal and external functions to ensure the generation and interpretation of high-quality bioanalytical and biomarker data supporting clinical development and regulatory submissions. The ideal candidate brings expertise in biomarker and protein-based assay development, experience managing external bioanalytical activities, strong scientific leadership, and the ability to translate biological questions into fit-for-purpose analytical strategies.

Serve as the bioanalytical representative on assigned discovery and development programs, providing scientific expertise and contributing to biomarker and bioanalytical strategies aligned with program objectives.

Develop and execute fit-for-purpose bioanalytical approaches (PK, ADA) and support the implementation of Biomarker methods (TE, PD, Disease) supporting the biomarker strategy.

Lead the design and execution of assay development, analytical validation, and sample analysis plans that support program and regulatory needs.

Provide scientific oversight of CROs and external laboratories, including assay development, validation, sample analysis, troubleshooting, data review, and vendor management.

Review protocols, validation reports, sample analysis reports, and bioanalytical data packages to ensure scientific quality, regulatory compliance, and fitness-for-purpose.

Support investigation of assay-related issues, deviations, and root cause analyses, providing scientific recommendations for corrective actions.

Develop, optimize, transfer, and validate bioanalytical and biomarker assays on various platforms on existing and emerging analytical platforms.

Evaluate and implement novel biomarker technologies, assessing platform performance and suitability based on context of use.

Monitor assay performance, data quality, QC trends, robustness, and cross-study comparability throughout the assay lifecycle, ensuring data integrity and scientific rigor.

Interpret bioanalytical data and communicate findings, risks, and recommendations to project teams and functional stakeholders.

Contribute scientific content and data packages supporting IND, CTA, BLA, and other regulatory submissions.

Support audits and inspections through preparation and review of bioanalytical documentation and study records.

Contribute to scientific publications, conference presentations, and the advancement of best practices in biomarker sciences, bioanalysis, and CRO management.

You are a scientifically rigorous bioanalytical expert who thrives on developing, qualifying, and implementing biomarker, pharmacodynamic, translational, and target engagement assays supporting discovery through clinical development.

You are motivated by driving high‑quality, clinically relevant bioanalysis and immunogenicity strategy, and you excel at interpreting data in a cross‑functional, fast‑paced environment.

You enjoy partnering with internal teams and CROs, providing clear scientific direction, and ensuring assays meet regulatory and program needs.

You communicate clearly, work independently, and bring strong judgment to problem‑solving, regulatory interactions, and strategic decision‑making.

• PhD or MS in Immunology, Cellular and Molecular Biology, or a related scientific field.
• PhD with 5+ years of relevant industry experience
• MS with 8+ years of relevant industry experience
• Experience developing and implementing biomarker and bioanalytical assays across discovery and clinical development settings.
• Advanced technical expertise in method development and validation in a regulated environment
• Experience supporting sample…