Travere Therapeutics

Director

• 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

Senior Director, Intellectual Property

Accounting Manager

• 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

Associate Director, Revenue and Gross-to-Net Accounting

Vice President

• 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

Vice President, Enterprise Effectiveness

Operations

• 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

Associate Director, Technical Operations – CMC Strategy

Translator

• Serve as the immunology lead supporting a late-stage clinical development program
• Contribute to the development and execution of nonclinical and translational strategies aligned with program team objectives
• Partner with cross-functional teams to support program governance, development planning, and scientific decision-making
• Assess emerging scientific, clinical, and competitive developments relevant to assigned program and associated strategy
• Develop translational strategies linking mechanism of action, target engagement, pharmacodynamic activity, and clinical outcomes
• Collaborate with Regulatory and nonclinical colleagues to support regulatory submissions and health authority interactions
• Lead scientific interactions with CROs, academic collaborators, consultants, and key opinion leaders

Director, Translational Immunology

Content Writer

• Responsible for oversight and authoring of regulatory submissions and other regulatory, clinical, and safety documents
• Contributing to the strategy of document development and project management during drafting and approval cycles
• Ensure documents are compliant and completed on-time and on-budget
• Support projects across all phases of clinical development and post-marketing life cycle management
• Serve as the medical writing lead for regulatory submissions and provide strategic guidance to study teams
• Lead and manage comment resolution meetings
• Mentor junior writers as applicable

Associate Director, Medical Writing

• Provide strategic leadership for safety surveillance and safety science activities
• Lead ongoing benefit-risk evaluations and recommend appropriate risk mitigation strategies
• Represent DSPV on cross-functional governance committees and development teams
• Perform medical review of ICSRs from clinical trials and postmarket reports
• Participate in Medical Data Review
• Lead safety signal management activities and oversight of vendor delegated to conduct signal detection
• Contribute to the planning, preparation, writing, review and QC of aggregate safety reports
• Review and contribute to safety sections of key study documents
• Ensure ongoing assessment of risk minimization effectiveness and regulatory compliance
• Serve as a subject matter expert during regulatory inspections and audits

Director, Drug Safety – Pharmacovigilance

Program Manager

• Lead cross-functional program planning and execution across clinical, regulatory, commercial, access, manufacturing, medical and nonclinical functions
• Organize and lead strategy team meetings: set agendas, clarify objectives, document decisions, and proactively ensure accountability for action items
• Develop and maintain integrated and often detailed development plans, timelines, budgets, and risk management frameworks
• Identify critical path activities, interdependencies, and risks; proactively implement mitigation strategies
• Coordinate program governance, including pro-active planning for decisions, identifying correct forum for decision making and leading the preparation of decision-ready materials
• Partner with Program Lead and Alliance manager in managing alignment, communication and governance with our partner
• Promote cross-functional alignment, transparency, and accountability to achieve development and commercialization milestones
• Partner with Finance on program budgeting and forecasting; ensure alignment and manage process for executive endorsement
• Contribute to departmental and corporate process improvements

Senior Director, Program Management

Compliance

• 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

Director, Regulatory Affairs Strategy

Marketing

• Lead the development and execution of comprehensive U.S. payer and reimbursement strategies to maximize patient access, product adoption, and long-term brand performance
• Develop segment-specific value propositions and access strategies tailored to stakeholders
• Serve as the primary market access representative on launch readiness, brand planning, and lifecycle management teams
• Lead market access launch planning and readiness activities to support a successful PegT commercialization
• Establish foundational strategies across pricing, contracting, patient support services, trade and distribution, payer engagement, reimbursement, and access analytics
• Partner with cross-functional teams to identify and mitigate market access risks and barriers prior to launch
• Lead development of payer-focused value communications, including AMCP dossiers, value dossiers, economic models, payer presentations, and other evidence-based resources
• Ensure all market access materials are scientifically rigorous, compliant, and aligned with brand strategy
• Collaborate with Medical Affairs, HEOR, and Commercial teams to strengthen stakeholder perceptions of PegT's clinical, economic, and humanistic value
• Lead development of launch pricing recommendations, gross-to-net strategies, and payer contracting approaches
• Partner with Finance, Commercial Operations, and Market Access leadership to evaluate pricing scenarios and business implications
• Monitor market dynamics and competitive trends to inform pricing and access decisions throughout the product lifecycle
• Partner with HEOR and Medical Affairs to identify evidence gaps, prioritize payer-relevant research, and shape evidence-generation strategies
• Guide post-hoc analyses, economic modeling, and real-world evidence initiatives that support payer decision-making
• Monitor payer policy changes, reimbursement trends, competitor strategies, and legislative developments to proactively adjust market access plans
• Collaborate closely with field market access, reimbursement, medical, marketing, government affairs, legal, and commercial teams to align on access objectives and execution plans
• Develop and manage market access research, consulting, and promotional budgets
• Support promotional review processes and ensure market access materials comply with legal, regulatory, and corporate standards

Senior Director, Metabolic Market Access Strategy – Marketing

• Develop and execute a multi-year digital innovation and AI strategy aligned with Development, Enterprise Technology, and corporate objectives
• Identify opportunities to transform development processes through establishment of an eClinical Systems Ecosystem Strategy
• Build and maintain a prioritized roadmap of digital initiatives focused on maximizing business value, operational efficiency, quality, and scalability
• Drive adoption of digital-first ways of working across the organization
• Lead initiatives that improve process efficiency, reduce cycle times, eliminate manual work, and enhance decision quality across Development functions

Senior Director, Digital Innovation and Strategy – R&D

• 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.

Associate Director, Bioanalytical Sciences

• responsible for the design, leadership, and implementation of Modeling & Simulation strategies across Travere clinical programs
• perform or supervise execution of the pharmacometrics strategy
• set the strategy for addressing pharmacometric issues in regulatory submissions
• lead and drive PMX contributions to integrate relevant technical and scientific knowledge
• use state of the art modeling and simulation approaches to interpret PK/PD data
• guide empirical modeling/QSP approaches to understand relationship between PK, biomarkers and disease outcomes

Director, Pharmacometrics, Clinical Pharmacology

• Serve as Medical Monitor for assigned clinical studies (Phase 1–3 and post marketing)
• Conduct timely medical review of eligibility questions, protocol deviations, dosing decisions, stopping rules, and emergent safety issues
• Support investigator engagement, including safety related medical guidance and training on risk mitigation measures
• Lead or support clinical event review (AEs, SAEs, AESIs)
• Provide medical input into informed consent forms, safety sections of protocols/IBs, and study level safety management plans
• Contribute to ongoing benefit risk assessments by integrating clinical, nonclinical, and real world safety information
• Participate in safety review meetings and provide medical input into risk mitigation and communication strategies
• Ensure safety activities adhere to GxP, ICH guidelines, and applicable global regulations

Senior Director, Medical Monitor – Safety Physician

• Global Development Physician Lead for assigned development programs as part of the Program Strategy Team (PST) and represents the program to executive leadership and study team members
• responsible for effectively communicating program goals, strategies, plans, issues and risks with team members, department heads, review boards, and the executive team
• deep understanding of working with cross-functional team members to create clinical development plans, timelines, risk tradeoffs including regular engagement/presentations with regulatory agencies is critical
• responsible for leading the development of protocols and clinical/scientific strategy for Phase 1-4
• understanding of the development and regulatory strategy (from pre-IND to NDA/BLA) and devices (Human Factor studies) to provide clinical and scientific insights as part of the PST
• understanding and knowledge of the rare metabolic and genetic disease areas as well as the future landscape and treatment paradigm in order to provide strategic input into future development needs, biometrics analyses, publications, and core presentations
• partners with Biometrics to plan data entry, analysis, and interpretation for the PST and Medical Affairs colleagues
• accountable for clinical portions of protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, and benefit/risk ratios
• lead and mentor Clinical Development staff and consultants to foster a high-performance culture within the Clinical Development department
• proactively establishes and maintains relationships with stakeholders i.e., alliance partners, external companies, investigators, and key opinion leaders
• attend and present at investigator meetings and site initiation visits as applicable
• works cross-functionally with Medical Affairs and prepares manuscripts, posters, and other scientific communications and conducts presentations at scientific meetings
• understanding of governance and ability to represent the programs and key decisions at cross-functional governance meetings