Associate Director, Biomarker Analysis

Essential Job Functions and Responsibilities

• Manage GLP/GCLP bioanalytical CROs and CLIA clinical testing labs for development and implementation of bioanalysis (PK) and biomarker assays using LC/MS, hybrid LBA-LC/MS, or ligand-binding assay formats.
• Develop appropriate biomarker analysis strategy for Crinetics’ drug candidates supporting clinical and non‑clinical studies based on study objectives.
• Apply fit‑for‑purpose biomarker validation approaches compliant with FDA and global regulatory guidance in bioanalytical settings, following CMS/CLIA and ISO guidance for clinical biomarker assays.
• Review and finalize method validation protocols, stability studies, and bioanalytical reports.
• Participate in periodic audits of bioanalytical CROs and ensure accreditation compliance of CLIA clinical testing laboratories.
• Work with cross‑functional colleagues to determine assay needs, manage assay selection, sample analysis, and reporting of results within study timelines.
• Manage and negotiate scopes of work, budgets, and payment schedules for outsourced bioanalysis/biomarker assay activities; review invoices against vendor contracts to ensure accuracy.
• Contribute to bioanalytical sections of CSRs and other regulatory submission documents.
• Lead preparation of bioanalytical sections for regulatory submissions (IB, IND, NDA) and draft written responses to health authority bioanalytical queries.
• Perform other duties as assigned.

• Bachelor’s degree in a relevant scientific field with 10+ years of industry experience in bioanalytical/biomarker functions involving LCMS and ligand‑binding assay method development, sample analysis, and management of outsourced biomarker assay activities.
• Equivalent education and experience will be considered.
• At least 7+ years of supervisory experience.
• Strong scientific and operational background in small and large molecule bioanalytical and biomarker method development, validation, data interpretation, and reporting of sample analysis results.
• Thorough understanding of bioanalytical and biomarker methodologies, GLP/GCLP requirements, ICH guidelines, and FDA guidance for bioanalytical assay validation and sample analysis.
• Experience in CLIA clinical testing laboratories and central labs is a plus.
• Proven ability to oversee validation work and sample analysis at CROs; highly knowledgeable on domestic and international service providers.
• Familiarity with all stages of nonclinical and clinical drug development, including fit‑for‑purpose assay development strategy.
• Strong written, presentation, and verbal communication skills.
• Excellent track record of scientific publications is a plus.
• Authoring experience in bioanalytical sections of regulatory submissions is a plus.
• Experience overseeing bioanalytical CROs in China is a plus.

$158,000 - $197,000

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.