Travere Therapeutics

Title: Associate Director, Bioanalytical Sciences Job Description: Department: 106200 Research & Non-Clinical Dev Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: 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. #LI-Remote Travere is an EEO/AA/Veteran/Disability Employer Total Rewards Offerings: Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization. Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees. Target Base Pay Range: $150,000.00 - $195,000.00 - This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location. Travere will accept applications on an ongoing basis until a candidate is selected for the position. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer. If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.

• Lead strategic planning and execution across target healthcare organizations, aligning on shared clinical, operational, and economic priorities • Identify and prioritize key accounts using a data-driven lens of market opportunity, institutional fit, and engagement readiness • Develop tailored account engagement plans and reviews that elevate rare kidney disease care models • Build high-value relationships with C-suite leaders, line directors, nephrologists, P&T stakeholders, care pathway leaders, and multidisciplinary teams • Facilitate collaborative opportunities for co-developing best practices in clinical pathways, early diagnosis, and care transitions • Identify opportunities to expand access, improve diagnosis rates, and support durable kidney preservation strategies • Serve as the primary point of contact and orchestrator across internal partners including Medical Affairs, Field Medical (MSLs), Marketing, Thought Leader Liaisons (TLLs), Sales, Patient Advocacy, HEOR, Patient Services, and Market Access teams • Lead internal business planning for strategic accounts, ensuring coordination of unbranded education, peer-to-peer programs, REMS coordination, and clinical protocol implementation • Drive ecosystem collaboration to track key metrics, deliver regular performance updates, and action plans • Capture, synthesize, and communicate actionable insights to internal stakeholders to shape strategy, education, and access programs • Track and report progress against key account metrics including pathway adoption, patient identification trends, engagement outcomes, and resource utilization

• Partner with executive leaders and People Success Partners to align organizational strategies with enterprise and functional business priorities • Assess organizational effectiveness and identify opportunities to improve performance, scalability, decision-making, and cross-functional collaboration • Lead organization design initiatives, including operating model evolution, role clarity, team effectiveness, governance structures, and workforce alignment • Develop recommendations that balance business needs, employee experience, organizational health, and long-term growth objectives • Ensure organizational structures support career development, talent mobility, leadership effectiveness, and employee engagement • Equip and enable People Success Partners with frameworks, tools, and consultative expertise in organizational design, workforce strategy, organizational effectiveness, and change management to strengthen strategic business partnership and deliver effective organizational solutions • Facilitate executive and functional leadership discussions to align organizational design principles, decision right, operating model implications, and change readiness

• Serve as a subject matter expert for Microsoft Word, document formatting, style management, templates, and document production best practices • Perform advanced document formatting and publishing activities, including management of complex tables, figures, references, cross-references, automated numbering, table of contents generation, and document quality control • Manage document development timelines, review cycles, and comment resolution activities to ensure high-quality deliverables are completed on schedule • Develop, maintain, and improve standardized document templates, style guides, macros, and formatting tools to support efficient document development and regulatory submissions • Partner with Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, and other functions to ensure documents are submission-ready and comply with regulatory publishing requirements • Author and coordinate the preparation of clinical, regulatory, and safety documents, including protocols, protocol amendments, clinical study reports (CSRs), investigator brochures (IBs), CTD components, and other submission-related documents.

• Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing activities, ensuring timely resolution of technical issues across Phase I–III clinical and commercial products • Oversee formulation development of current approved drugs and new drug candidates • Manage and provide technical oversight of formulation development and cGMP manufacturing activities at contract manufacturing organizations (CMOs) • Support creation of integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies to support clinical and commercial milestones • Managing CMOs to develop and maintain methods for clinical/commercial production of finished dosage forms • Review and approve technical and GMP documentation, including specifications, Master Batch records, validation documents, change controls, and technical reports • Author, edit, review, and contribute to CMC sections of regulatory submissions, responses, and health authority interactions • Partner closely with Regulatory Affairs, Quality, Supply Chain, Clinical Operations, and Program Management to ensure alignment of CMC activities with development and commercialization goals • Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP and global regulatory requirements • Provide technical leadership, mentorship, and strategic guidance across Technical Operations and cross-functional teams • Support launch readiness and commercialization planning to ensure reliable product supply

• Perform monthly revenue and gross-to-net accounting processes, ensuring accurate and timely revenue recognition in accordance with ASC 606 • Own the calculation, review, and analysis of gross-to-net reserves and adjustments, including rebates, chargebacks, returns, discounts, and other revenue deductions • Prepare revenue-related journal entries, account reconciliations, analyses, and supporting schedules • Partner with Forecasting, FP&A, Market Access, Commercial, and Patient Access teams to support gross-to-net forecasting methodologies and assumptions • Evaluate revenue-related contracts and commercial arrangements and prepare technical accounting analyses and memoranda • Monitor and analyze gross-to-net trends, payer dynamics, and reimbursement changes to provide actionable business insights • Lead SOX compliance activities, internal controls, audit support, and process documentation related to revenue and gross-to-net accounting • Support commercialization activities, including new product launches, payer contracting strategies, and distribution channel changes • Drive process optimization, automation initiatives, and system enhancements to improve efficiency, scalability, and reporting accuracy • Assist in developing and mentoring accounting team members and fostering a culture of continuous improvement • Collaborate with Corporate Accounting and Financial Reporting teams to support quarterly and annual reporting requirements

• Manage and advise on assigned patent portfolios • Work with outside counsel on patent applications • Support regular portfolio reviews • Collaborate with VP, IP, and internal stakeholders • Provide IP support for drafting agreements • Lead intellectual property due diligence activities • Work closely with teams on emerging data • Manage outside IP counsel on assigned matters • Help develop scalable IP processes

• Partner with executive and senior leaders to identify opportunities to improve organizational effectiveness and enterprise performance • Build strong partnerships with Technology, Program Management, People Success, and other key stakeholders • Serve as an empowered, solutions-focused leader who proactively identifies organizational inefficiencies • Help the organization successfully navigate growth, increasing scale, and evolving business needs • Lead change management efforts associated with major business initiatives

• Execute CMC strategies aligned with corporate objectives for biologics program(s). • Develop and maintain integrated project plans, timelines, and resource forecasts. • Ensure effective communication of project status, risks, and opportunities; improve operational efficiency. • Facilitate team meetings, prepare agenda, publish meeting minutes, and ensure accountability for deliverables. • Monitor project progress and proactively identify, assess, and mitigate risks. • Coordinate CMC initiatives and activities, and partner with cross-functional teams to ensure readiness and timely delivery of technical documentation and regulatory commitments, and other CMC deliverables. • Align with internal and external stakeholders to support production schedules, supply planning, and inventory management to ensure uninterrupted product availability. • Additional duties assigned as needed.

• Develop and lead global regulatory strategies for Phase 2 and Phase 3 clinical development programs • Provide regulatory guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways • Evaluate regulatory risks and opportunities and develop mitigation strategies to support program objectives • Lead regulatory planning for major milestones, including End-of-Phase 2 meetings, Scientific Advice procedures, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, and marketing applications • Serve as the regulatory representative on cross-functional program teams and governance committees • Lead preparation, coordination, and execution of global regulatory agency meetings and interactions • Develop briefing documents, regulatory questions, meeting strategies, and response packages • Represent the company during regulatory agency meetings and negotiations • Ensure alignment of regulatory strategy across regions while addressing local market requirements • Oversee the preparation and submission of global regulatory documents, including: INDs and IND amendments, Clinical Trial Applications (CTAs), Annual reports and Development Safety Update Reports (DSURs), Pediatric plans and orphan drug submissions, NDA, BLA, MAA, and other marketing applications • Review and approve key submission documents to ensure regulatory compliance, scientific integrity, and strategic consistency • Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to integrate regulatory considerations into development plans • Provide regulatory leadership for label development and commercialization planning • Support due diligence activities, business development initiatives, and portfolio evaluations as needed • Mentor and develop regulatory staff and contribute to building organizational regulatory capabilities • Monitor evolving global regulatory requirements, guidance documents, and industry trends • Assess potential impact of regulatory changes on development programs and advise leadership accordingly • Ensure compliance with applicable regulatory regulations, guidelines, and company procedures