Director, Translational Medicine

Ribon Therapeutics is seeking a Translational Medicine lead, with a strong scientific background in cancer biology and biomarker research to build and lead the Translational Medicine group. 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 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.

Responsibilities

  • In collaboration with the drug discovery project teams, develop and implement biomarker strategies for preclinical drug discovery programs and their implementation in clinical studies in oncology
  • 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
  • Partner with biostatisticians and biomarker laboratories to establish biomarker analysis plans to ensure delivery of high-quality data to support analysis, interpretation and reports of clinical biomarkers for internal decision-making and Health Authority submissions
  • Identify, contract with and oversee external vendors to implement, validate and conduct clinical biomarker assay development
  • Identify, develop and implement innovative analytical methods which address biomarker needs in the first in class setting
  • Overseeing the development and monitoring the quality of pharmacodynamic and patient stratification biomarker assays to support the advancement of preclinical programs into the clinic
  • Overseeing 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 oncology, tumor biology and the competitive landscape


Experience and Education

  • Ph.D., Pharm.D., or M.Sc. with 8-15 years of relevant work experience, including a minimum of 3 years in development of biomarkers and translational medicine strategies during oncology drug development
  • Knowledge of biomarker development and implementation in early stage oncology 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. Experience with the development of companion diagnostics is a plus
  • A strong background in cancer biology, knowledge in immunotherapy and/or immuno-oncology 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, presentation, and communication 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 careers@ribontx.com.

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