Senior Scientist/Principal Scientist Translational Medicine
Ribon Therapeutics is seeking a Senior Scientist/Principal Scientist in Translational Medicine, with a strong scientific background in immunology/inflammation and biomarker research to contribute to translational research for first in class molecules. The successful candidate will be responsible for developing and implementing biomarker programs for drug discovery programs, proof of concept studies and first in human investigational trials. They will work closely with the science and clinical development groups to direct the translation of preclinical research into clinical applications, to develop, validate and implement biomarkers and assays in inflammation and oncology programs. This role embraces the principles of a translational medicine mindset, with a focus on operational excellence and deep scientific rigor. The ideal candidate will be passionate about first in class drug discovery and clinical implementation while working in an innovative and fast-paced small-company environment.
- In collaboration with drug discovery project teams, develop and execute biomarker strategies for preclinical drug discovery programs and their implementation in clinical studies in inflammatory diseases and oncology.
- Develop and deliver biomarker assays for clinical studies based on the best available science and technologies, with appropriate fit for purpose validation.
- Generate biomarker data to guide disease/indication selection and identification of select patient populations.
- Measure target engagement reliably and quantifiably to inform clinical decisions for selecting therapeutically relevant doses and schedules.
- In collaboration with the clinical group, is responsible for the biomarker aspect of clinical protocol design and writing, as well as authoring the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions and responses (INDs/CTAs) as well as co-authoring, assisting and supporting the development of publications, abstracts, and presentations.
- Identify, contract with, and oversee 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 (medical directors, nonclinical and discovery research scientists, regulatory) to ensure early definition of, and agreement on biomarker strategy for clinical development and regulatory approvals.
- Represent Translational Medicine in cross-functional project teams.
- Maintain up-to-date knowledge of scientific and clinical published literature in inflammatory diseases, tumor biology and the competitive landscape.
Experience and Education:
- Ph.D., Pharm.D., with 4+ years or M.Sc . with 12+ years of relevant work experience, including development of biomarkers and translational medicine strategies during drug development.
- Knowledge of biomarker development and implementation in early-stage drug development to support clinical assay development/validation for mechanism of action, proof of biologic activity, proof of concept, patient stratification and response prediction markers. Relevant skills include understanding of relevant techniques (flow cytometry, intracellular staining, cytotoxicity assays, ELISA, ELISpot, IHC, etc.), and molecular biology.
- A strong background in inflammation; knowledge of oncology, immunotherapy and/or immuno-oncology is a plus.
- Good understanding of relevant areas of biology and biomarker-based approaches. Knowledge of biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, and pharmacogenomics is a plus.
- Experience with contracting and overseeing external vendors, central laboratories and clinical research organizations to implement biomarker assay development and ensure execution excellence under cGCP/cGLP 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.
- Is productive and can work both independently and as part of cross-functional collaborative teams to ensure timely execution of biomarker strategy for clinical programs.
- Strong oral, written and presentations communications skills with the ability to represent the Translational Medicine within the organization.
If you are interested in joining Ribon’s team, please email your resume to [email protected]