Senior Director, Clinical Development
Core
Lead clinical study portfolio and strategy for a blood-based cancer detection platform using machine learning on whole-genome sequencing data.
Role type
Senior Director, Clinical Development
Builds
Clinical evidence for IVD diagnostic products (e.g., FirstLook Lung) to support FDA approval, reimbursement, and product launch.
Domain
Oncology diagnostics / In Vitro Diagnostics (IVD) / Genomics
Deliverable
production ML models | product features
Required skills
Clinical study design, clinical operations, oncology expertise, IVD diagnostics development, regulatory standards (ICH GCP, ISO 13485), team management, stakeholder engagement
Preferred skills
AI in clinical trials (NLP, LLM, digital twins), international data standards (FAIR, FHIR-OMOP)
Technologies
Whole-genome sequencing, machine learning, case-control study design, prospective study design
Responsibilities
Develop and execute clinical studies for clinical validity and utility; implement five-year clinical development strategy; manage clinical operations groups and CROs; interact with FDA on IVD submissions; present at scientific meetings
Seniority
Senior Director, strategic leadership & cross-functional management
