Associate Director, Biomarker Analysis

Crinetics Pharmaceuticals

Associate Director of Biomarker Analysis at Crinetics Pharmaceuticals managing bioanalysis and biomarker activities for drug development. Collaborating with cross-functional teams and leading regulatory submissions.

Posted 6/17/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $158,000 - $197,000 per yearWebsite

About the role

Key responsibilities & impact

Manage GLP/GCLP bioanalytical CROs and CLIA clinical testing labs
Develop appropriate biomarker analysis strategy
Apply fit-for-purpose biomarker validation approach
Review and finalize method validations protocols, stability studies, and bioanalytical reports
Participate in the periodic audit of bioanalytical CROs
Work with cross-functional colleagues in various programs
Manage and negotiate scopes of work, budget, and payment schedules
Review invoices against vendor contracts
Contribute to bioanalytical reports and regulatory documents
Lead preparation of bioanalytical sections in regulatory submissions
Lead bioanalytical function on written responses to health authority bioanalytical queries

Requirements

What you’ll need

Bachelor’s degree in a relevant scientific field
10+ years of industry experience in a bioanalytical/biomarker function in LCMS and ligand-binding assay (LBA) method development
7+ years of experience in a supervisory role
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 laboratory and central lab is a plus
Proven ability to oversee validation work and sample analysis at CRO
Highly knowledgeable on domestic and international service providers
Familiarity with all stages of nonclinical and clinical drug development
Strong written, presentation and verbal communication skills
Excellent track record of scientific publications is a plus
Authoring experience in bioanalytical sections in regulatory submissions is a plus
Experience in oversight of bioanalytical CROs in China is a plus

Benefits

Comp & perks

Health insurance plans for employees and their families (medical, dental, vision and basic life insurance)
20 days of PTO
10 paid holidays
Winter company shutdown
Discretionary annual target bonus
Stock options
401k match

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

bioanalytical method developmentbiomarker validationLCMSligand-binding assay (LBA)data interpretationsample analysismethod validation protocolsstability studiesregulatory submissionsbioanalytical reports

Soft Skills

leadershipnegotiationcross-functional collaborationcommunicationpresentationscientific writingorganizational skillsoversightproblem-solvingaudit participation