Role Summary
We are seeking a dynamic, scientifically rigorous Principal Scientist, Translational Lead to drive translational strategy and execution across early-stage clinical programs. This cross-functional role combines biological insight, data fluency, and operational pragmatism, ideally suited for a candidate with a strong translational medicine background who is also comfortable performing hands-on analytics and drafting infrastructure requirements.
Responsibilities
- Drive translational strategy for early-phase clinical programs, incorporating biomarker hypotheses, patient selection, and endpoint optimization.
- Serve as the lead for biomarker components in clinical protocols, IND submissions, and regulatory engagements.
- Align translational goals with key clinical milestones and trial objectives.
- Design and execute analysis plans for high-dimensional datasets including flow cytometry, RNA-seq, single-cell, and spatial omics.
- Lead integration of molecular and clinical data to uncover pharmacodynamic signals, stratification markers, and mechanisms of resistance.
- Automate and analyze complex flow cytometry and CyTOF datasets using tools such as FlowJo, R (e.g., flowCore, CytoML, ggcyto), or Python-based pipelines.
- Apply modern statistical and machine learning methods to uncover actionable insights, ensuring analytic reproducibility and compliance.
- Contribute to governance meetings, internal reviews, and external scientific communications (e.g., manuscripts, abstracts).
- Provide thought leadership at the interface of clinical development and translational science.
- Evaluate new biomarker platforms and external datasets to expand translational capabilities.
- Mentor junior scientists and cultivate a high-performing, collaborative translational culture.
Qualifications
- PhD in Bioinformatics, Computational Biology, Immunology, Molecular Biology, or related discipline.
- 8+ years of industry experience in translational medicine, biomarkers, or bioinformatics in oncology, immunology, or rare disease.
- Proficiency in automated flow cytometry analysis, including multicolor panel data interpretation and integration with other biomarker modalities.
- Hands-on fluency in R and/or Python for statistical modeling, data visualization, and reproducible bioinformatics.
- Demonstrated ability to design and execute translational analysis plans and influence clinical development.
- Experience contributing to INDs or regulatory filings involving biomarker or flow cytometry data.
- Familiarity with early-phase trials in cell therapy, immuno-oncology, or engineered therapeutics.
- Experience working in GCP/GxP-regulated environments or defining analytics/compliance workflows.
- Exposure to tools such as FlowJo, Cytobank, Spectre, or Bioconductor-based cytometry packages.
- Background in small biotech or matrixed R&D settings with high execution ownership.
Skills
- Biomarker discovery and translational data integration
- High-dimensional data analysis (flow cytometry, transcriptomics, proteomics)
- Statistical modeling and machine learning for translational science
- Cross-functional collaboration and scientific communication