Principal Scientist - Biomarkers

Job Description

Job Description

The Principal Scientist, Biomarkers, will lead the development and execution of biomarker strategies for assigned programs, connecting discovery research with translational medicine and clinical development.

Working closely with Research, Clinical Development, and external partners, you will translate disease biology into practical biomarker plans, oversee their implementation, and interpret results in the context of program objectives. This opportunity is well-suited to a scientist who combines scientific depth with hands-on problem-solving and wants to influence how targeted therapeutics advance toward meaningful patient benefit.

KEY RESPONSIBILITIES 

• Develop and execute plans to assess target engagement, pharmacodynamic activity, mechanism of action, and potential markers of treatment response or patient selection.
• Partner with Research and Translational Medicine to evaluate candidate biomarkers, establish their biological relevance, and determine whether they can be measured reliably in clinically accessible samples.
• Define hypotheses, experimental approaches, and interpretation criteria that strengthen understanding of disease biology and therapeutic activity across nonclinical and clinical studies.
• Work with internal scientists and external laboratories to develop, transfer, qualify, and implement biomarker assays with performance appropriate to their intended use and development stage.
• Partner with Clinical Development, Clinical Operations, and other functions on biomarker endpoints, sampling schedules, protocol content, and laboratory requirements, balancing scientific value with patient burden and operational feasibility.
• Contribute to laboratory and CRO selection, define scientific deliverables and timelines, review assay performance and results, and resolve issues affecting data quality or delivery.
• Coordinate with operational partners on collection, processing, storage, shipment, and testing requirements for tissue, cell, and biofluid samples to preserve sample integrity and interpretability.
• Turn biomarker data into development recommendations. Integrate findings with exposure, safety, and efficacy data in partnership with clinical, quantitative, and computational colleagues. Explain what the results support, where uncertainty remains, and which next steps are warranted.
• Communicate priorities, progress, risks, and resource needs; recommend tradeoffs; and align biomarker deliverables with program milestones.
• Prepare scientific reports, presentations, and contributions to regulatory documents and publications. Share expertise and mentor colleagues to improve experimental rigor, documentation, and interpretation.
• Perform experiments in the lab as needed and record experiment protocols and results in ELN.

REQUIREMENTS

• PhD in biology, immunology, pharmacology, biomedical sciences, or a related discipline.

• 6+ years of relevant biotechnology or pharmaceutical industry experience in biomarker science, translational research, or translational medicine, including responsibility for biomarker activities supporting drug development.

• Demonstrated experience developing and implementing biomarker plans that address program questions and inform development decisions.

• Strong understanding of disease biology and the application of biomarkers to target engagement, pharmacodynamic assessment, mechanism of action, and patient stratification.

• Experience working with human biological samples and evaluating the scientific and practical considerations that affect sample quality, assay performance, and interpretation.

• Scientific expertise in relevant assay technologies, such as flow cytometry, immunoassays, PCR-based methods, tissue imaging, or sequencing-based approaches, with the ability to select methods appropriate to the biological question.

• Experience developing or overseeing biomarker assays, including evaluating sensitivity, specificity, precision, reproducibility, and sample stability as appropriate to their intended use.

• Experience coordinating external laboratories, CROs, or academic collaborators, including defining work, reviewing results, troubleshooting issues, and managing deliverables.

• Strong analytical judgment, including the ability to integrate multiple data types, distinguish biological findings from technical variability, and communicate the limitations of an analysis.

• Working knowledge of clinical development, biomarker implementation in clinical studies, and applicable quality, documentation, and human-sample-handling requirements.

• Demonstrated ability to lead scientific work across functions, manage competing priorities, and communicate clear recommendations to scientific and clinical colleagues.

• A collaborative, accountable approach and the willingness to contribute directly to critical work in a fast-moving environment.

ADDITIONAL EXPERIENCE WE VALUE

• Biomarker development in rare disease, hematology, or hematologic oncology.
• Supporting first-in-human or early clinical proof-of-concept studies.
• Integrating biomarker findings with pharmacokinetic, safety, or clinical outcome data.
• Applying genomic, transcriptomic, proteomic, or single-cell approaches to translational questions.
• Contributing biomarker content to regulatory submissions, scientific publications, or conference presentations.
• Working in an emerging biotechnology company with evolving programs and priorities.