DELFI Diagnostics, Inc.
Healthcare
Sr.Director,ClinicalDevelopment
“Sr. Director, Clinical Development at DELFI Diagnostics, Inc.. Skills: Clinical development strategy, Clinical study execution, Diagnostics product development. Develop clinical studies. Execute clinical studies”
What You'll Achieve.
Save lives globally; Detect cancer early; Deliver impact with conviction
Industry & Context.
Rapidly prioritize; Triage
What They're Looking For.
Must Have
PhD in physical or natural sciences, or MD, 8+ years leading clinical study design & development, 3-5 years IVD diagnostics development, Knowledge of ICH E6(R3) GCP, Knowledge of ISO 14155, Knowledge of ISO 13485, Knowledge of 21 CFR Part 820, 6-8 years management experience, Excellent communication skills
Nice to Have
Disciplinary expertise in cancer biology, Familiarity with AI approaches in clinical trials, Familiarity with NLP or LLM for EHRs, Familiarity with digital twins, Familiarity with digital pathology, Familiarity with FAIR principles, Familiarity with FHIR-OMOP, Familiarity with Common Data Models
What You'll Do.
Develop clinical studies
Execute clinical studies
Generate robust evidence
Advance diagnostic product development
Implement clinical development strategy
Partner to design clinical studies
Analyze clinical studies
Manage clinical development groups
Manage clinical operations groups
Manage affiliated CROs
Develop clinical trial timelines
Manage clinical trial timelines
Develop clinical trial budgets
Manage clinical trial budgets
Develop clinical trial risks
Manage clinical trial risks
Identify evidence gaps
Generate real-world data
Collaborate to store clinical data
Collaborate to curate clinical data
Collaborate to cross-reference clinical data
Participate in industry groups
Present to senior leadership
Present at scientific meetings
Present at clinical meetings
How You'll Work.
Team & Collaboration
Cross-functional teams; Senior leadership; R&D teams; Medical teams; Quality teams; Regulatory teams; Biostatistics teams; Data Engineering teams
Communication Scope
Written presentations; Oral presentations; Large-group forums; Small-group forums
Process & Methodology
Clinical trial timelines, Clinical trial budgets, Clinical trial risks
Applying for this Sr. Director, Clinical Development role?
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