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Senior Director, Clinical Development
Delfi DiagnosticsSr. Director leading clinical development at DELFI Diagnostics for blood-based cancer tests.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
clinical study designclinical trial managementbiostatisticsclinical validityclinical utilityIVD diagnostics developmentpublication recordproduct development processesrisk managementbudget management
Soft Skills
leadershipcommunicationcoachingperformance managementcareer developmentproactivedecisiveinnovativeaccountablestart-up mindset
Certifications & Qualifications
PhDMD
Industry Keywords
cancer diagnosticsclinical development strategyICH E6(R3) GCPISO 14155ISO 1348521 CFR Part 820cross-functional teamsclinical operationsCRO managementclinical science
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