FirstLook Lung is a blood-based test that helps identify lung cancer risk before or alongside LDCT, for USPSTF-eligible adults. From DELFI Diagnostics. Backed by Menlo.
About the role
The Sr. Director, Clinical Development provides leadership across DELFI's clinical study portfolio, working closely with senior leadership and cross-functional teams including R&D, medical, quality, and regulatory. This leader helps to direct the comprehensive strategy for all DELFI clinical studies and to execute on our key trials supporting product development, launch, and reimbursement. We seek an adaptable, rigorous, and collaborative leader who is solidly grounded in clinical development.
What they're looking for
- PhD in the physical or natural sciences, or MD. Disciplinary expertise in cancer biology strongly preferred
- 8+ years' expertise leading the design & development of clinical studies for either pharmaceutical or diagnostics development, as evidenced by a strong publication record or successful product releases
- 3–5 years' experience in IVD diagnostics development
- Knowledge of relevant clinical & regulatory standards such as ICH E6(R3) GCP, ISO 14155, ISO 13485, 21 CFR Part 820
- 6–8 years' management experience including best practices in recruiting, coaching, performance management, and career development
- Excellent communication skills including mastery in written & oral presentations, large- and small-group forums
More about this role
About Us
DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.
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