Position Summary
- Principal Scientist (Cell Therapy Translational Research) in Seattle, WA supporting cell therapy development programs in autoimmune and inflammatory diseases.
- Drive translational development strategies and clinical biomarker plans for cellular therapy clinical studies; design, execute, and interpret translational experiments and analyses with CROs and internal/external collaborators.
- Identify biomarkers; generate/analyze data supporting pharmacodynamic evaluation and mechanism of action; support global regulatory submission activities.
Responsibilities
- Develop and implement end-to-end translational research strategies for cell therapy clinical trials.
- Partner with biostatisticians and computational biologists to analyze, communicate, and contextualize data.
- Develop mechanism-of-action hypotheses and identify distinguishing characteristics of products alone or in combination.
- Maintain deep understanding of biomarker assays (flow cytometry, transcriptomics, proteomics) and their clinical-trial use.
- Independently manage internal drug-development projects; lead scientific cross-functional teams/committees.
- Oversee/manage CROs and academic collaborators.
- Present internally/externally; contribute to investigator brochures, IND applications, clinical protocols, regulatory reports, and other regulatory documents.
- Support regulatory submissions; write/review translational sections for global responses/queries.
Basic Qualifications
- Bachelorβs: 8+ years academic/industry experience; OR Masterβs: 6+ years; OR PhD/equivalent: 4+ years.