Clinical Biomarker Lead

Position

Clinical Biomarker Lead

Direct Report

Position Summary

This role will work with Translational Medicine lead to define a clinical biomarker plan that will facilitate go/no go decision-making. This role will also be responsible for identifying and managing vendors/CROs to facilitate the implementation and execution of biomarker plan into clinical study as well as preparing and reviewing biomarker sections of relevant documents (i.e. candidate nomination documents, clinical protocols and documents submitted to regulatory affairs).

Key Responsibilities

  • Work closely with Translational Medicine lead to design a clinical biomarker plan for ascertaining target binding/engagement and to potentially uncover biomarkers predictive of patient response
  • Identify and manage vendors/CROs and external collaborators to facilitate implementation and execution of biomarker plan into clinical study, and to generate quality data that is delivered in a timely manner
  • Collaborate with Translational Medicine lead to analyze and interpret biomarker data and to present conclusions and recommendations to larger team
  • Collaborate with medical directors, clinical pharmacologists, nonclinical and discovery research scientists to ensure agreement on biomarker needs for clinical development strategy. Part of the team that provides strategic, technical, and scientific leadership for development, implementation, and data interpretation of an integrated translational research strategy for assigned programs
  • Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to regulatory affairs

Qualifications

  • Ph.D 2+ years or Masters 4+ years or Bachelors 7+ years of experience. Degree in field of Biology, Oncology and/or Immunology preferred
  • 3+ years industry experience in clinical biomarkers, particularly in the field of immuno-oncology. Companion Diagnostics experience a plus
  • Must be capable of utilizing the highest scientific and technical standards for the successful design and execution of clinical biomarker strategies implemented in early clinical programs in a timely manner
  • An understanding of the clinical development process and trial design
  • Strong leadership abilities
  • Strong administrative and multi-tasking skills
  • In-depth experience managing vendors/CROs