Travere Therapeutics

General

• Serve as the Company's senior scientific advisor to the Executive Team and Board of Directors
• provide scientific insight and strategic counsel that informs portfolio prioritization, corporate strategy, business development, capital allocation, and long-term growth
• Partner with the Executive Team to shape portfolio strategy
• Own and communicate the Company's scientific vision, innovation strategy, and long-term research roadmap
• Define and evolve the Company's long-term scientific strategy
• Continuously assess emerging science and technology to inform portfolio strategy and future growth
• Elevate Travere's scientific reputation by cultivating relationships with leading investigators, academic institutions, scientific societies, innovation partners, and the broader rare disease community
• Provide executive leadership, strategic direction, and organizational oversight for the Research organization
• Lead the scientific evaluation and due diligence of external opportunities
• Partner with the Head of Research to build and continuously evolve a world-class research organization
• Build organizational depth through succession planning, strategic hiring, and leadership development
• Provide executive leadership and strategic direction for the Technical Operations organization
• Develop and execute a long-term Technical Operations strategy
• Champion technical innovation across formulation, analytical sciences, process development, manufacturing sciences, device integration, and external manufacturing partnerships

Chief Scientific Officer

Learning and Development

• Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease
• Support Medical Affairs learning and development initiatives while providing strategic and operational support for Medical Information activities.
• Focus on Medical Affairs learning and development initiatives, including onboarding, scientific education, competency development, certification programs, and ongoing training for Field Medical and Medical Affairs personnel.
• Support Medical Information operations through oversight of scientific content development, response document management, inquiry trend analysis, and collaboration with cross-functional stakeholders to ensure timely, accurate, balanced, and compliant dissemination of medical information.
• Partner closely with Medical Affairs, Medical Information, Clinical Development, Regulatory, Legal, Compliance, Market Access, and Commercial colleagues to develop innovative learning solutions, optimize scientific communication resources, and enhance organizational effectiveness across the Medical Affairs function.

Senior Manager, Medical Affairs Training – Medical Information

Medical Director

• Provide scientific leadership and help execute the Global Medical Affairs strategy and tactical plan for civorebrutinib (EVER001)
• Develop and maintain deep scientific expertise in civorebrutinib, immune-mediated renal kidney diseases, the competitive landscape, emerging clinical data, and evolving standards of care.
• Lead the global KOL engagement strategy, including identification, prioritization, scientific exchange, and long-term relationship development with key opinion leaders, investigators, professional societies, and patient advocacy organizations.
• Oversee the planning, development, execution, and measurement of scientific engagement activities, including advisory boards, expert panels, investigator meetings, and other scientific forums.
• Partner with Scientific Communications to develop and execute scientific messaging, the Scientific Communication Platform (SCP), publication strategy, congress strategy, and medical education.
• Collaborate with Clinical Development to support the civorebrutinib clinical trial program, including investigator and site engagement, and medical support as needed.

Medical Director, Global Medical Affairs, Nephrology

Account Manager

• Responsible for positioning the company as a leader in the Nephrology space and maximizing sales in their territory
• Call on Health Care Professionals (HCPs) specializing in Nephrology in targeted institutions and offices
• Provide educational support to an underserved patient community
• Assist with steps to provide access of therapies for patients

Clinical Account Manager

Translator

• Serve as a preclinical biology lead or key scientific contributor for evaluation of business development opportunities ranging from small-molecule to biologics at all stages of development, including external assets, platform-based technologies and research-based collaborations.
• Assess scientific rationale, mechanism of action, disease biology, pharmacology and toxicology data, translational relevance and therapeutic safety window, biomarker strategy, and development feasibility for potential opportunities.
• Review and interpret nonclinical and translational data alongside clinical, regulatory, and competitive information to identify strengths, risks, gaps, and key value drivers.
• Partner with Business Development and cross-functional diligence teams to develop scientific assessment reports, diligence questions, risk summaries, and recommendations.
• Identify critical experiments, analyses, or expert input needed to reduce scientific uncertainty for potential opportunities.
• Support evaluation of strategic fit with Travere’s portfolio, therapeutic areas of interest, rare disease focus, and translational development capabilities.
• Provide translational pharmacology expertise across preclinical and clinical-stage opportunities, including interpretation of in vitro, in vivo, ex vivo, biomarker, pharmacodynamic, and clinical pharmacology data.
• Evaluate whether available pharmacology and translational data support proposed mechanisms of action, target engagement, dose rationale, patient selection, and clinical development strategy.
• Integrate mechanistic biology, pharmacology, biomarker, and clinical observations to assess therapeutic potential and development risk.
• Stay abreast of industry trends, emerging technologies, advances in disease biology and therapeutic targets and competitive activities to inform search strategies and evaluations relevant to Travere’s areas of interest.
• Lead or contribute to scientific interactions with external companies, academic collaborators, CROs, consultants, key opinion leaders, and subject matter experts during diligence and collaboration activities.
• Identify and engage external experts to inform evaluation of disease biology, pharmacology, biomarkers, clinical translation, and development risk.
• Support assessment of external research proposals, collaboration opportunities, and emerging scientific areas relevant to Travere’s strategic interests.
• Interpret pharmacology, toxicology, translational, and biomarker data in the context of potential clinical development and regulatory expectations.
• Contribute to evaluation of whether available nonclinical packages are adequate to support current or proposed clinical development plans.
• Contribute to development plans and budget for selected opportunities, including translational strategy, nonclinical pharmacology and safety needs, biomarker plans, and early clinical development considerations.
• Support preparation and review of relevant sections of investigator brochures, briefing documents, regulatory submissions, and development-related documents as needed.
• Provide scientific leadership within a collaborative, matrixed Research and Nonclinical Development organization.

Director, Translational Pharmacology

Procurement

• Develops outsourcing strategies and plans for R&D departments, with focus on Clinical Studies
• Acts as the lead point of contact for R&D financial needs including procurement
• Lead competitive sourcing initiatives, RFP development and bid analysis
• Evaluate outsourcing models and provide recommendations that balance quality, timelines, operational feasibility, and financial impact
• Provides input into the negotiation of financial business terms and conditions, and management of all R&Ds contracts in close cooperation with the other departments
• Supports and coordinates discount programs with key vendors
• Assists in negotiating vendor business terms in contracts such as scope, price, payment terms, and service level agreements
• Develop and maintain forecasts for clinical programs and other R&D activities, providing visibility into projected spending, risks, and opportunities
• Monitor actual spending against budget and forecast, identify variances, and provide actionable recommendations to stakeholders
• Support monthly and quarterly financial close activities, including accrual calculations, invoice forecasting, and budget reconciliation
• Analyze resource utilization, vendor spend trends, and portfolio investment requirements to support strategic decision-making
• Collaborate with Finance and R&D leadership to develop long-range planning assumptions and multi-year development cost projections
• Support the preparation of executive-level reporting and dashboards on R&D expenditures, study financial performance, vendor spending, and key financial metrics
• Champion continuous improvement initiatives that optimize procurement, outsourcing, financial governance, and operational effectiveness
• Additional duties assigned as needed

Associate Director, Strategic Procurement

QA Engineer

• Lead, manage and perform critical Quality Assurance (QA) GMP functions providing oversight of GMP Contract Service Providers (CSPs) for Drug Substance and Drug Product activities/projects leading up to Phase 3 Process Validation and Commercialization
• Leads validation efforts, projects, and action items including validations of: Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning, Test Methods, and Computer System Validation
• Develop, execute, review, approve and/or oversee various aspects of a validation activities, including but not limited to: Master Plan (VMP) Validation Plan (VP) User Requirements Specifications (URS) Process Failure Mode and Effects Analysis (FMEA) of the process Process Characterization (PC) and Process Understanding (PU) studies Factory Acceptance Test (FAT) Site Acceptance Test (SAT) Commissioning Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Process Validation (PV) protocols/reports
• Direct Support of contract manufacturing, testing, storage and distribution organizations including, but not limited to: Change Control Deviations/Quality Events OOS/OOT investigations Corrective Actions and Preventive Actions Risk Management Vendor qualification and auditing Contractor qualification
• Collaborate closely with the Technical Operations Department for review and approval of CSP documentation for the above functionality
• Provide technical input to Travere Polices, SOPs, Work Instructions, etc., assuring internal needs are defined while complying with Regulatory requirements, Guidance and/or industry standards
• Review and approve Travere GxP related documents as requested
• Ensure compliance with applicable laws, regulations and guidelines for Travere Therapeutics’ contract manufacturing organizations
• Participate in the project core teams and sub-teams as needed and assigned
• Track progress versus timelines and goals

Director, Quality Assurance – Technical

• Lead and support analytical qualification, validation, and transfer of analytical methods for small and large molecules
• Review, approve and/or oversee various aspects of analytical validation activities
• Serves as the primary point of contact for Travere cross functional groups and contract vendors for analytical questions
• Provide subject matter expertise in aiding risk assessment activities
• Support product(s) stability program with review and approval of protocols
• Support the analytical review of data for regulatory submissions

Associate Director, Quality Assurance – Technical

Product Operations

• Technical oversight of production and scale up of drug product manufacture
• Review and approve manufacturing related documents
• Verify suitability and qualification of processes
• Provide technical support for quality systems governing GMP manufacturing
• Collaborate on CMC development and commercialization of drug product
• Author and review technical documents and regulatory filings
• Maintain up-to-date knowledge of US and EU GMPs and regulatory guidance
• Provide technical recommendations to leadership

Associate Director, Technical Operations – Drug Product

Operations

• Provide technical oversight for drug substance manufacturing activities supporting late-stage clinical and commercial biologics programs at Travere’s CDMOs
• Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, process characterization (PC) and PPQ protocols and reports
• Serve as technical resource for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections
• Monitor process performance data, identify process trends, and recommend improvements to increase process robustness, product quality, and manufacturing efficiency
• Support tech transfer and process scale-up at CDMOs
• Partner with Regulatory Affairs to prepare technical documentation supporting CMC sections of IND, BLA, and regulatory agency responses
• Author technical reports on a variety of manufacturing related subjects
• Support lifecycle management activities, including process optimization, post-approval changes, and continued process verification (CPV)

Associate Director, Technical Operations – Biologics Drug Substance Manufacturing

Controller

• Lead the Company’s accounting organization, including general accounting, monthly and quarterly financial close, technical accounting, SEC reporting, inventory and cost of goods sold accounting, financial systems, and internal controls
• Oversee the preparation and review of accurate and timely consolidated financial statements, including detailed analysis of domestic and international operations
• Oversee all SEC reporting activities, ensuring filings are timely, complete, accurate, and compliant with applicable SEC regulations and disclosure requirements
• Lead technical accounting research and the preparation of U.S. GAAP accounting position papers and technical accounting memoranda
• Develop processes to proactively identify and assess business events with potential accounting implications and effectively manage internal and external technical accounting resources
• Monitor emerging accounting standards and lead the implementation of new accounting pronouncements across the organization
• Oversee global accounting activities related to foreign subsidiaries, including consolidations, intercompany transactions, foreign currency accounting, and statutory reporting requirements
• Support strategic business initiatives, including mergers and acquisitions, licensing and collaboration agreements, financing transactions, purchase accounting, and post-acquisition integration activities
• Partner closely with Legal, Tax, FP&A, Information Technology, Human Resources, Supply Chain, and other cross-functional leaders to support business initiatives and ensure appropriate accounting treatment and financial governance
• Lead Finance transformation initiatives, including ERP optimization, financial systems enhancements, automation, data governance, and continuous process improvement to improve efficiency, scalability, reporting quality, and internal controls
• Maintain and continuously strengthen the Company’s SOX compliance program and internal control framework
• Develop, implement, and monitor policies, procedures, and controls to ensure compliance with U.S. GAAP, SEC regulations, and corporate governance requirements
• Oversee and maintain a comprehensive system of accounting policies and procedures, ensuring consistency, compliance, and operational excellence
• Serve as the primary point of contact for external auditors and other third-party advisors, leading quarterly reviews, annual audits, SEC-related activities, and other corporate accounting matters
• Assist in the preparation and presentation of financial information and accounting matters for the Audit Committee and Board of Directors, including communicating complex accounting issues in a clear and effective manner
• Oversee ERP and other accounting systems, ensuring systems effectively support business operations, financial reporting, internal controls, and future organizational growth
• Drive continuous improvement of the financial close process, reporting timelines, and accounting operations through standardization, automation, and best practices
• Build, lead, mentor, and develop a high-performing accounting organization through coaching, succession planning, talent development, goal setting, and ongoing performance management

Vice President, Controller

Financial Planning and Analysis

• Lead the Company's financial planning and analysis function
• Serve as the principle strategic advisor to the Chief Financial Officer (CFO) and Executive Leadership Team (ET)
• Lead enterprise-wide resource allocation and portfolio investment analyses
• Represent Finance with external stakeholders
• Lead the financial evaluation, due diligence, and integration planning for mergers and acquisitions
• Develop and enhance integrated financial models, forecasting methodologies, and analytical tools
• Oversee financial performance reporting
• Partner closely with leaders across the organization to align financial plans with business priorities
• Lead the transformation of Finance processes and systems

Vice President, Financial Planning & Analysis

Content Writer

• Author and coordinate the preparation of regulatory, clinical, and safety documents
• Lead cross-functional collaborations with stakeholders to develop, review, and finalize high-quality documents
• Manage document development timelines, review cycles, and comment resolution activities
• Interpret, analyze, and summarize complex clinical and scientific data into clear, accurate, and submission-ready content
• Ensure adherence to applicable FDA, EMA, ICH, and other relevant regulatory guidelines and industry standards
• Proactively contribute and lead development and continuous improvements of medical writing processes, capabilities, templates, style guides, and standard operating procedures

Senior Manager, Medical Writing

Director

• Lead the Statistical Programming function within the Biometrics Department
• Provide strategic input and leadership to the delivery of statistical programming contributions across all clinical development projects
• Overall accountability of programming deliverables required to support the analysis and reporting for clinical development projects
• Provide statistical programming and validation support for clinical study reports
• Coordinate programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, and electronic submissions
• Lead and contribute to the development and review of case report forms, clinical DB specifications, SAP, and reporting specifications
• Ensure quality of all project programming deliverables
• Conduct vendor qualifications and GCP audits (in collaboration with QA)
• Identify and lead the application of programming methodologies to support all aspects of the clinical development process
• Manage programmers and contribute to the professional development of Biometrics personnel by conducting trainings and coaching

Executive Director, Statistical Programming

Compliance

• Provide regulatory leadership and execution support for late-stage development programs
• Contribute to the implementation of global regulatory strategies
• Support regulatory planning, submission execution, Health Authority interactions, and major regulatory milestones
• Manage activities performed by regulatory consultants and external vendors