Summary:
Our client is seeking an experienced Biomarker and Translational Sciences leader to join the Translational Research team. A successful incumbent would help integrate basic science research, proteomics, genomics and informatics to advance clinical development of therapeutics for autoimmune diseases. 

Position Responsibilities:

• • Design and implement clinical biomarker and exploratory translational strategies; adhere to clinical and regulatory submission protocols.
  • Successfully manage CROs and establish relationships to develop biomarker assays, monitor assay qualification/validation at CROs, as well as biomarker testing in the clinic.
  • Collaborate with clinical operations and the central lab to support clinical sample management and logistics.
  • Perform integrative analysis of clinical biomarker data and drug response data for baseline and on-treatment biomarker discovery for clinical programs.
  • Drive decisions to support PK/PD, immunogenicity, and predictive biomarker analysis in clinical studies.
  • Ensure quality and timely submission of all clinical biomarker -related documents and materials for regulatory filings, including scientific advice filings, INDs, meeting briefing books, and other requests from global regulatory authorities.

Candidate Requirements:

• • Ph.D in Immunology or related field.
  • 5 or more years of industry (biotech/pharmaceutical) clinical biomarker experience in autoimmune diseases including but not limited to lupus and rheumatoid arthritis.
  • Deep understanding of the pre-clinical, translational, and clinical stages of drug development in the immunology and/or autoimmunity field.
  • Extensive working knowledge of biomarker assay development and the ability to critically evaluate emerging technologies in the clinical biomarker space.
  • Experience in selection and management of external CROs.
  • Hands-on experience with interpretation of flow cytometry data in clinical trials is required.
  • Experience with analysis of clinical biomarker data on gene expression, multi-plex histology and soluble biomarkers is preferred.
  • Experience leading within and collaborating effectively as a member of a cross-functional team.
  • Demonstrable knowledge of appropriate quality standards including ICH/GCP, and global regulations.
  • Excellent analytical skills, with an ability to communicate complex issues in a simple way.