*NEW* LEADER IN ASSAY DEVELOPMENT/VALIDATION – BIOMARKERS

If you are looking for the next-step in your career and want a visible, influential role with a financially sound, scientifically innovative company where you can have a significant impact on emerging therapeutic modalities, this could be your opportunity! Our client, a financially sound, global mid-sized pharma, is on the cutting edge of innovation and drug discovery/development technologies advancing therapeutics that have a major, transformative (not just incremental) impact on patients. On the scientific track at an Assoc. Dir./Director level, you will lead development of protein and nucleic acid-based approaches for patient selection, target engagement, and biological/clinical response biomarkers.

Responsibilities

  • Provide expert oversight to develop, validate, and deploy various assays for a range of tissue types (body fluids to solid tissue) for preclinical / clinical decision making with focus on clinical assay development.
  • Working in a matrix environment as the point of contact re. requirements for assay design for patient selection, target engagement, and MOA biomarkers.
  • Oversee assay development at CROs
  • Interface with Regulatory team re requirements for assay validation.
  • Work cross functionally with clinical, translational, and regulatory colleagues to ensure regulatory requirements are met in time for clinical use, including supporting documentation for assay characteristics and validation.
  • Establish relationships with external vendors and CROs that will implement assays.

Qualifications.

  • MD or PhD degree with post-graduate experience AND 8-10+ years experience in biomarker assay development and validation for assays to be used in clinical trials for drug approvals.
  • Experience developing protein, nucleic acid, and molecular pathology assays in a variety of disease areas.
  • Strong mentorship skills
  • Excellent people skills for driving collaborations across a global, matrixed organization.
  • Companion Dx development outside of oncology a strong plus.
  • Experience with leading clinical biomarker-related regulatory interactions
  • Demonstrated track record of success working on cross functional multidisciplinary teams
  • Ability to act proactively and effectively applying creative problem-solving skills
  • Excellent strategic planning, organizational and communication skills (including, written and oral presentation skills)

Must have N. American residency and US work authorization or be TN visa eligible.

To apply for this position, confidentially email us here.