Head of Clinical Operations

Everest Detection

Everest Detection is a private biotechnology company focused on early cancer detection. Cancer continues to be a deadly and devastating disease, and most lung and ovarian cancers (Everest’s focus) are detected at late stages. Everest’s mission is to non-invasively detect cancer early, when surgery and therapy offer potential cures. Our research team is based in San Francisco, and we operate effectively as a virtual organization for other functions. We offer highly competitive compensation including salary, equity ownership, health and dental benefits and the opportunity to be a part of a growing team of dedicated scientists. The company recently raised a round of financing that will provide years of funding to support our assay development activities.


Role Overview

As Head of Clinical Operations (Director/Sr Director/VP based on experience) at Everest Detection, you will establish and lead a team responsible for acquisition of clinical samples and associated longitudinal clinical data to support biomarker discovery through clinical assay validation, along with the strategic planning and execution of pivotal clinical studies. This is an opportunity to be part of a small, nimble team at a dynamic startup company and play a strategic role in translating biomarker discovery into a clinically validated assay to transform early cancer detection. The person in this position will play an important leadership role at the company and report to the CEO.


Essential Duties and Responsibilities

  • Oversee the day-to-day function of our clinical operations team and collaborate with biomarker discovery and assay development and validation teams to support all stages of LDT development and ensure biospecimen requirements and project timelines are fulfilled
  • Hire and manage a growing Clinical Operations team, ensuring their development, training and growth opportunities
  • Implement, oversee, and audit LIMS to manage and track clinical samples and associated longitudinal clinical data
  • Develop, track and monitor laboratory analytics to ensure a high quality biospecimen bank
  • Establish and manage contracts with research collaborators, KOLs and CROs to support collection of clinical samples and longitudinal data and achieve on-time enrollment for pivotal clinical trial
  • Provide strategic input and leadership in clinical study design and execution
  • Oversee selection and management of electronic data capture system (EDC)
  • Implement and assure compliance with all regulatory requirements for clinical lab activities including standard operating procedures (SOPs), GCP and FDA requirements
  • Prepare well written study related protocols, consent documentation, clinical trial agreements, and documents for regulatory agencies
  • Manage clinical study budgets and track progress against department budget
  • This position can be fully remote



  • Ph.D., M.D., M.S. or B.S. in Life Science, Biomedical Laboratory Science, Clinical Science or related field
  • 8+ years of relevant experience in Diagnostic Clinical Operations developing and commercializing LDTs; previous experience working with FDA submission process including premarket approval (PMA)
  • Broad familiarity with data management and electronic data management systems, biostatistical principles for study design and data analysis, and regulatory compliance
  • An exceptional leader with demonstrated ability to build and retain high performing teams
  • Able and willing to travel to clinical study sites and CROs