Associate Director, Bioanalytical Sciences

About the role

Travere Therapeutics is seeking an experienced and strategic scientist to join our Research and Nonclinical Development organization as Associate Director, Bioanalytical Sciences.

Responsibilities

• 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

• 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.
• Experience supporting global clinical studies involving multiple clinical sites, central laboratories, and bioanalytical testing laboratories.
• Experience contributing to regulatory submissions and development documentation.

Additional Skills/Experience/Requirements

• Deep understanding of regulated bioanalysis, assay validation, and global regulatory expectations.
• Strong understanding of biomarker strategy and clinical development support.
• Experience supporting both biologic and small molecule development programs preferred.
• Experience with biomarker assays used for diagnosis, disease monitoring, target engagement, or pharmacodynamic assessment preferred.
• Experience supporting global regulatory submissions across multiple geographic regions preferred.
• Prior leadership experience in matrixed development organizations preferred.
• Excellent communication, collaboration, and project leadership skills.
• Ability to thrive in a fast-paced, cross-functional biotechnology environment.