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regulatory submissions assay development elisa pharmacodynamics biomarker📋 Description
- Lead assay development, validation, and translational biomarker strategies.
- Integrate biomarkers into clinical development and decisions.
- Manage vendor CRO relationships and data quality.
- Provide scientific leadership across discovery to clinical ops.
- Supervise and mentor scientists and technical staff.
- Drive IND-enabling criteria and go/no-go decisions.
🎯 Requirements
- M.S. or Ph.D. in biology or related field.
- 10+ years translational biomarker experience.
- Proven assay development: cell-based, biochemical, ELISA, multiplex, Western blotting.
- Experience transferring assays to CROs and regulatory filings support.
- Strong understanding of GCP and regulatory expectations.
- Excellent written and oral communication; leadership and cross-functional collaboration.
🎁 Benefits
- Comprehensive health care with premiums covered.
- Mental health support via Spring Health.
- Hybrid work model with flexible locations.
- Unlimited paid time off and parental leave.
- 401K with employer match and employee stock purchase program.
- Subsidized lunch via Forkable on office days.
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