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Senior Director, Clinical Development
Delfi DiagnosticsSr. Director leading clinical development at DELFI Diagnostics for blood-based cancer tests.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Leadership across DELFI's clinical study portfolio, working with senior leadership and cross-functional teams including R&D, medical, quality, and regulatory.
- Develop and execute clinical studies that generate robust evidence for DELFI's products, including establishing clinical validity and utility.
- Advance DELFI's development of diagnostic products for cancer.
- Implement the five-year clinical development strategy based on clinical science and unmet needs in cancer diagnostics.
- Partner with R&D Biostatistics for clinical studies and analyze in accordance with protocols.
- Manage clinical development & operations groups and associated CROs and investigators.
- Develop and manage clinical trial timelines, budgets, and risks in accordance with product development processes.
Requirements
What you’ll need- 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.
- 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.
Benefits
Comp & perks- flexible time-off policy
- 401(k) retirement plan
- extremely competitive medical, dental, and vision coverage
- onsite lunch 3 days a week
- other wellness related offerings
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical study designclinical trial managementbiostatisticsclinical validityclinical utilityIVD diagnostics developmentpublication recordproduct development processesrisk managementbudget management
Soft Skills
leadershipcommunicationcoachingperformance managementcareer developmentproactivedecisiveinnovativeaccountablestart-up mindset
Certifications
PhDMD