Senior Director, Clinical Development

Clinical Study Development & Operations

• Develop and execute clinical studies that generate robust evidence for DELFIs current and future pipeline of product claims including studies that establish clinical validity and clinical utility.

• Advance DELFIs 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 DELFIs product(s).

• Collaborate with Data Engineering to store curate and cross-reference DELFIs clinical data.

Communication Thought Leadership & Outreach

• Participate in industry stakeholder groups and consortia such as BLOODPAC or the Global Alliance for Genomics and Health.

• Present to senior leadership company-wide and at key national scientific and clinical meetings.

Required

• 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.

• 35 years experience in IVD diagnostics development.

• Knowledge of relevant clinical & regulatory standards such as ICH E6(R3) GCP ISO 14155 ISOCFR Part 820.

• 68 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.

• Start-up mindset: passionate innovative accountable able to rapidly prioritize and triage biased to action.

• Proactive decisive and composed with a balance of high IQ & EQ.

Preferred

• Familiarity with cutting-edge AI approaches in clinical trials (NLP or LLM for EHRs digital twins digital pathology) as well as international data standards such as FAIR principles FHIR-OMOP or Common Data Models.