Sr. Director, Clinical Development

About this Role

What You'll Do

Clinical Study Development & Operations

Develop and execute clinical studies that generate robust evidence for DELFI's current and future pipeline of product claims, including studies that establish clinical validity and clinical utility.

Advance DELFI's development of diagnostic products for cancer, with the detection of lung cancer in USPSTF-eligible individuals as the first indication.

Play a key role in implementing the five-year clinical development strategy based on the latest clinical science, evidence gaps, and unmet needs in cancer diagnostics.

Partner with R&D Biostatistics to design case-control and prospective clinical studies, and to analyze those studies in accordance with statistical analysis plans and study protocols.

Manage the clinical development & clinical operations groups and affiliated CROs and investigators, including vendor selection/management/monitoring, site selection, patient enrollment and follow-up.

Develop and manage clinical trial timelines, budget, and risks in accordance with overall product development processes and plans.

Regulatory & Evidence Management

Interact with FDA on submissions for IVD product approval, including face-to-face/virtual meetings and written presubmissions in coordination with Regulatory Affairs.

Author relevant sections of IVD documents pertaining to clinical development activities, design controls, requirements, etc.

Work closely with Medical Affairs to identify evidence gaps and generate real-world data for DELFI's product(s).

Collaborate with Data Engineering to store, curate, and cross-reference DELFI's clinical data.

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