Associate Director Clinical Diagnostics
Job Summary
Leading companion diagnostic (CDx) strategy and development, the full-time remote Associate Director Clinical Diagnostics will manage programs from early biomarker feasibility through clinical validation and regulatory submission, ensuring diagnostics align with therapeutic milestones.
Key responsibilities
- Translate biomarker and mechanism-of-action data into diagnostic target product profiles, defining assay intent across various platforms
- Design biomarker strategies for patient selection and stratification in collaboration with translational and clinical teams
- Oversee analytical and clinical validation planning, linking assay performance to clinical safety and efficacy endpoints
Required qualifications
- PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related field
- 8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs
- Proven track record of translating biomarker science into validated assays supporting drug approvals
- Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA)
- Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions
Complete Job Description
The complete job description is available to members. Premium membership includes:
Full access to 40,222 remote jobs from human-vetted companies, updated daily
Resume Builder - AI-powered tool to craft, enhance, and tailor your resume to a specific job
Twice-monthly live group coaching and the full Remote Career Center
20% member discount on Career Services
Backed by a 30-day money-back guarantee
Company Company Name
Headquarters Headquarters
Founded Founded
Website
Wikipedia Wikipedia URL
BBB URL BBB URL
The company description is available to members. Go Premium for full access to every job and company profile in our remote jobs database, backed by a 30-day money-back guarantee.
