Jobbörse

Travere Therapeutics is seeking an experienced and strategic scientist to join our Research and Nonclinical Development organization as Associate Director, Bioanalytical Sciences. This individual will provide scientific, operational, and cross-functional leadership for bioanalytical activities supporting nonclinical and clinical development programs across the portfolio.

The successful candidate will bring expertise in regulated bioanalysis supporting both small molecule and biologic development programs, including ligand-binding assay (LBA) platforms for biomarker, diagnostic, target engagement, pharmacodynamic, and immunogenicity applications, as well as LC-MS/MS methodologies supporting pharmacokinetic and metabolite analyses. The individual will work closely with DMPK, Translational Sciences, Clinical Pharmacology, Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Quality, and external partners to develop and execute bioanalytical strategies that support global clinical development, regulatory submissions, and data-driven decision making.

This role serves as the functional bioanalytical lead on multidisciplinary program teams and is responsible for end-to-end oversight of bioanalytical activities spanning assay strategy, CRO oversight, sample lifecycle management, data review, and regulatory support.

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.
• Additional duties assigned as needed.

Education/Experience Requirements:

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Pharmacology, or a related scientific discipline. Equivalent combination of education and applicable job experience may be considered.
• 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.

Additional Skills/Experience/Requirements:

• Deep understanding of regulated bioanalysis, assay validation, and global regulatory expectations.
• Strong understanding of biomarker strategy and clinical development support.
• Ability to integrate bioanalytical, PK, biomarker, and clinical data to inform development decisions.
• 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.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.