My client is expanding and seeks a Translational Scientist for inflammation and oncology programs. The ideal candidate will take on the following tasks:
- Develop and execute biomarker strategies for preclinical drug discovery programs and their implementation in clinical studies.
- Generate biomarker data to guide disease, indication selection, and identification of select patient populations.
- Develop and deliver biomarker assays for clinical studies based on the best available science and technologies, with appropriate fit for purpose validation.
- Measure target engagement reliably and quantifiably to inform clinical decisions for selecting therapeutically relevant doses and schedules.
- Collaborate with external vendors to implement, validate, and conduct clinical biomarker assay development.
- Oversee the design and implementation of biomarker analysis in clinical trials, ensuring operational execution by partnering with biomarker labs and data management according to cGCP guidelines.
- Working with a cross functional team, ensure agreement on biomarker strategy for clinical development and regulatory approvals.
- Maintain knowledge of scientific and clinical published literature in inflammatory diseases, tumor biology and the competitive landscape.
The ideal candidate will possess the following qualities:
- PhD or MS and experience developing biomarkers and translational medicine strategies during drug development.
- Experience with biomarker development and implementing early-stage drug development to support clinical assay development and validation for MOA, POC, patient stratification and response prediction markers.
- Experience with flow cytometry, intracellular staining, cytotoxicity assays, ELISA, ELISpot, IHC, and molecular biology.
- A strong background in inflammation; knowledge of oncology, immunotherapy and/or immuno-oncology is a plus.
- Experience collaborating with external partners to implement biomarker assay development and ensure execution excellence under GxP guidelines.
- Demonstrated organizational skills, aligning available resources to meet goals.
- Strong interpersonal skills and demonstrated ability to establishing effective collaborative relationships with internal stakeholders and external parties to ensure execution excellence.
Title and salary are commensurate with experience.