Associate Director, Biomarker Analysis
$158,000–$197,000 year
Remote · United States
Job Summary
Associate Director of Biomarker Bioanalysis will manage outsourced bioanalysis (PK) and biomarker activities, oversee platform/assay selection, development, validation, and utilization in nonclinical and clinical development; develop fit-for-purpose biomarker analysis strategies for Crinetics’ drug candidates; ensure compliance with FDA/CLIA/ISO guidance; review and finalize validation protocols, reports, and audits; lead bioanalytical sections in regulatory submissions (IB, IND, NDA); manage CROs and CLIA labs, negotiate scopes of work and budgets, and contribute to regulatory documents. Travel up to 5-10% may be required. Strong background in LCMS and LBA method development, validation, data interpretation, and cross-functional collaboration is essential; excellent communication skills and track record of scientific publications are a plus.
Required Qualifications
- Bachelor’s degree in a relevant scientific field
- 10+ years of industry experience in bioanalytical/biomarker function in LCMS and LBA
- 7+ years in a supervisory role
- Strong knowledge of GLP/GCLP, ICH, and FDA guidance for bioanalytical assay validation
- Experience in CLIA clinical testing laboratory and central lab is a plus
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