Associate Director, Bioanalytical Sciences

Travere Therapeutics

Associate Director leading bioanalytical strategies for biopharmaceutical development at Travere Therapeutics. Overseeing bioanalytical activities and collaborating with cross-functional teams to support clinical programs.

Posted 6/16/2026full-timeSan Diego • California • 🇺🇸 United StatesSenior💰 $150,000 - $195,000 per yearWebsite

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Hard Skills

bioanalytical strategiesbioanalytical methodsLBALC-MS/MSassay developmentvalidationsample analysisregulatory submissionsdata qualitybiomarker strategies

Soft Skills

strategic oversightcollaborationleadershiprelationship managementproblem-solvingcommunicationvendor performance monitoringoperational planningquality assurancescientific integrity

Tools & Technologies

CROscentral laboratoriesbioanalytical testing laboratoriesclinical operationsdata managementlaboratory manualssample handling proceduresGCLPGLPFDA compliance

Certifications & Qualifications

PhD in Analytical ChemistryPhD in Pharmaceutical SciencesPhD in BiochemistryPhD in BiologyPhD in Pharmacology

Industry Keywords

biopharmaceutical industryregulated bioanalysisclinical developmentnonclinical developmentglobal clinical studiesbiomarkertarget engagementpharmacodynamic assessmentimmunogenicitydisease monitoring

About the role

Key responsibilities & impact

Serve as the functional lead for Bioanalytical Sciences on cross-functional development teams.
Develop and execute phase-appropriate bioanalytical strategies aligned with program objectives, timelines, and regulatory requirements.
Provide strategic oversight of bioanalytical methods supporting PK, TK, biomarker, diagnostic, target engagement, pharmacodynamic, and immunogenicity analyses.
Lead development, qualification, validation, transfer, and implementation of LBA and LC-MS/MS methods through external partners.
Collaborate with Translational Sciences and Clinical Development teams to implement biomarker strategies supporting disease monitoring, patient stratification, target engagement, and pharmacodynamic assessment.
Partner with Clinical Development, Clinical Operations, Biometrics, Data Management, and laboratory vendors to support protocol development, laboratory manuals, sample handling procedures, and bioanalytical operational plans.
Oversee collection, processing, shipment, reconciliation, analysis, and reporting of bioanalytical samples across global clinical studies.
Ensure timely transfer, review, reconciliation, and delivery of bioanalytical data to internal stakeholders, including Biometrics and Regulatory Affairs.
Develop and maintain strategic relationships with CROs, central laboratories, and specialty testing laboratories.
Monitor vendor performance and resolve scientific, operational, and quality-related issues.
Support global regulatory submissions and ensure bioanalytical activities comply with applicable FDA, EMA, and other international regulatory requirements.
Partner with Quality group on GCLP/GLP vendor audits and regulatory pre-approval inspections.
Review bioanalytical reports and data packages to ensure scientific integrity, regulatory readiness, and data quality.

Requirements

What you’ll need

PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Pharmacology, or a related scientific discipline
Minimum 4 years of relevant experience in the biopharmaceutical industry
Significant experience in regulated bioanalysis utilizing LBA and/or LC-MS/MS platforms supporting clinical and nonclinical development
Demonstrated experience overseeing assay development, validation, and sample analysis through CRO partners
Experience supporting global clinical studies involving multiple clinical sites, central laboratories, and bioanalytical testing laboratories
Experience contributing to regulatory submissions and development documentation

Benefits

Comp & perks

premium health
financial offerings
work-life and well-being offerings for eligible employees and dependents
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off