Travere Therapeutics

Medical Director

• Lead the overall clinical development strategy for assigned program(s) as a key contributor to indication strategy, target product profile, clinical positioning, and lifecycle planning.
• Serve as the project lead for clinical programs, integrating nonclinical, translational, biomarker, safety, regulatory, and competitive insights into development plans.
• Design and oversee clinical studies across phases, including protocol concept, eligibility criteria, endpoints, safety monitoring, dose selection, and statistical considerations.
• Provide leadership for study conduct, including protocol deviation review and data interpretation.
• Lead analysis and interpretation of clinical data and author or review key documents including protocols, IBs, CSRs, abstracts, manuscripts, and health authority briefing materials.
• Partner with Biometrics to define analysis strategy and ensure clinically meaningful interpretation of efficacy, safety, PK/PD, and biomarker data.
• Serve as the project leader for assigned development program(s), driving cross-functional alignment on program goals, timelines, risks, decision points, and resource needs.
• Lead core team meetings and represent the program at governance forums, providing clear recommendations grounded in data, development risk, and strategic fit.
• Build integrated development plans in collaboration with cross-functional partners and ensure disciplined execution against milestones.
• Identify program risks early and develop mitigation strategies spanning clinical, regulatory, operational, and portfolio considerations.
• Drive scenario planning and decision analyses to support stage-gate and investment decisions.
• Contribute to global regulatory strategy and represent Clinical Development in interactions with regulatory agencies, including FDA, EMA, and other health authorities.
• Help prepare for and participate in key regulatory meetings, including end-of-Phase 2 and other milestone interactions.
• Build and maintain relationships with academic experts, investigators, patient advocacy groups, and other external stakeholders in nephrology and rare disease.
• Support due diligence and business development activities, including assessment of external assets in nephrology or adjacent rare disease areas.
• Partner closely with Clinical Operations to ensure study designs are executable and enrollment strategies are realistic for rare disease settings.
• Collaborate with Non-Clinical teams to incorporate mechanistic and disease-relevant endpoints into development programs.
• Productively interface with Clinical Pharmacology, Pharmacovigilance, CMC, HEOR, Medical Writing, and additional project functional leads not previously listed.
• Work with Medical Affairs and Commercial colleagues to align development plans with future evidence-generation needs and patient/community insights.
• Mentor junior project team members and contribute to building a high-performing clinical development organization.
• Model strong enterprise leadership, balancing program advocacy with portfolio-level thinking.

Executive Medical Director, Clinical Development Nephrology

Communications

• provides portfolio-level strategic leadership and governance for Travere's scientific communications function
• ensuring publications, medical education, congress planning, and scientific content are aligned to advancing Global Medical Affairs
• sets the multi-year scientific communications plan
• builds scalable infrastructure to support current and future pipeline assets
• leads the strategy and integration of scientific communications across publications, medical education, and congress planning

Executive Director, Scientific Communications

Data Scientist

• Act as the single point of accountability for data management deliverables at an assigned level within a given clinical development program
• Serve as Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to DM
• Manage system integrations across data platforms
• Ensure CRO and third-party data review outputs are reviewed according to agreed plans and filed in the Trial Master Plan as appropriate
• Perform ongoing data review of clinical data to identify data discrepancies, general data trends, and corresponding resolutions as part of oversight over the CROs
• Review data for protocol deviation identification, dictionary coding, and perform user acceptance testing of database
• Review documents produced by vendors and other departments
• Create data management process documents such as data management plans, data review specifications, data transfer agreements, diagram workflows, timelines and communication plans
• Work cross-functionally with other departments within the company assessing and understanding their needs
• Strategize and plan for database locks and multiple deliverables across numerous studies within a program ensuring consistency in process
• Provide input on the development of standard operating procedures (SOPs) and study protocols from a data management perspective
• Provide guidance to clinical data management personnel on assigned projects
• Set-up, maintain and archive data management related project documentation (i.e., Data Management Plan, CRF Completion Guidelines, etc.)
• Independently monitor own activities and project status for successful project deliverables according to timelines
• Adhere to budgets and timelines
• Ensure project is in reasonable state of inspection readiness and compliance

Principal Clinical Data Manager

QA Engineer

• Actively supporting the implementation of GLP initiatives
• Leading the execution of quality related activities
• Conducting audits of pharmaceutical laboratories
• Evaluating laboratory systems including method validation and sample management
• Preparing comprehensive audit plans and reports
• Managing vendor oversight and issue management
• Conducting investigations of GLP/GCLP Quality Events
• Leading the development and delivery of laboratory quality and compliance related training

Senior Laboratory Auditor, Quality Assurance GLP

Manager

• The Access & Reimbursement Manager (ARM) will be a subject matter expert on access & reimbursement for FILSPARI (Sparsentan)
• Provide education and case-specific support to internal and external stakeholders including but not limited to health care providers (HCPs) and sales force within their assigned region
• Cultivate the highest level of expertise in the FILSPARI onboarding process, from Patient Start Form (PSF) submission through REMS enrollment to reimbursement
• Walk offices through what to expect from the FILSPARI onboarding process
• Educate physicians and physician practices on the full FILSPARI onboarding process
• Closely monitor cases as they progress through the onboarding process
• Proactively identify and solve complex patient access issues
• Educate physicians (in-person or virtual) on escalated reimbursement issues
• Assist physicians and office staff when PSFs or REMS enrollment forms are submitted with information missing
• Effectively partner with reimbursement stakeholders to communicate challenges, identify solutions, and ensure the patient is progressing through the reimbursement process
• Maintain a level of expertise on specific payors and the requirements for claim approvals
• Log calls and notes within standardized platform daily
• Lead weekly case status update meetings with sales force and sales leadership

Access & Reimbursement Manager

• responsible for the design, leadership, and implementation of Modeling & Simulation strategies across Travere clinical programs
• perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches
• set the strategy for addressing pharmacometric issues and directly influences drug development decisions
• developing and executing modeling and simulation strategies from the early through late-stage clinical development
• serve as the SME in cross-functional development program teams
• play a key role in delivering strategic and well-timed modeling input at key decision points along the development path
• set the strategy for addressing pharmacometric issues in regulatory submissions
• lead and drive PMX contributions to integrate technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies
• 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

Senior Manager, Pharmacometrics, Clinical Pharmacology

Director

• Be a part of a global team that aims to make a difference in the lives of patients with rare diseases
• Serve as the accountable safety physician for clinical trials
• Lead Medical Monitor for assigned clinical studies (Phase 1–3 and/or post-marketing)
• Oversee clinical event review, ensuring subject safety and protocol compliance
• Provide medical oversight of signal detection activities from clinical trials, literature, spontaneous reports, and partner data
• Represent the organization as the senior medical safety authority in health authority interactions

Executive Director, Medical Monitor, Safety Physician

Operations

• maintaining field data accuracy and data stewardship
• facilitating clear communication between headquarters and field teams
• coordinating field operations projects
• review and ensure accurate and consistent field data across systems
• steward data change management, processes, and validations
• collaborate cross-functionally to optimize data processes
• define project scope, timelines, deliverables, and documentation
• serve as the liaison between Field Operations and field teams
• develop and distribute proactive communication materials
• manage operational training, instructions and reminders

Senior Field Operations Specialist

• Develop and execute a multi-year engagement strategy across major nephrology organizations
• Serve as the primary Medical Affairs lead for professional societies and their scientific advisory councils
• Expand engagement beyond sponsorships & annual congresses to sustained, strategic collaboration
• Lead engagement strategy with guideline committees and compendia decision-makers
• Partner with Ev Gen, Clinical Development, HEOR, and Scientific Communications to align evidence generation and publication timing
• Define KPIs that measure impact beyond sponsorship metrics

Director, Scientific Engagement – Professional Societies

• Serve as the strategic architect of Travere’s Medical Affairs–led evidence infrastructure.
• Define and execute a multi-year integrated evidence strategy spanning post-approval interventional and non-interventional studies, investigator-sponsored research (ISR), collaborative research, real-world evidence (RWE), and lifecycle management (LCM).
• Chair the Evidence Generation Committee and act as the senior medical authority on post-approval and lifecycle evidence.
• Partner cross-functionally to strengthen Travere’s scientific credibility and long-term asset value.
• Serve as a key member of the Nephrology Medical leadership and contribute to broader TA priorities based on experience, expertise, and evolving organizational needs.
• Define and lead a 3–5-year integrated evidence roadmap aligned to lifecycle and access priorities.
• Identify and address evidence gaps supporting label expansion, new subpopulations, combination strategies, durability, and long-term safety.

Senior Medical Director – Integrated Evidence Generation, Nephrology

• Work closely with the Biometrics Project Lead in providing statistical support to clinical studies
• Serve as the lead statistician of late-stage trials and drive statistical strategy & execution
• Oversee statistical aspects of trials to ensure all requirements are met
• Provide statistical knowledge in study design, analysis, reporting, and interpretation
• Conduct statistical analyses and oversee external vendors
• Collaborate with cross-functional teams to ensure quality of Biometrics deliverables
• Contribute to the development of Biometrics-related SOPs and technical documents
• Research and apply new statistical methodologies as needed

Associate Director – Biostatistics

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
• 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

• Develop and own the enterprise omnichannel orchestration strategy aligned to brand, portfolio, and corporate objectives
• Define the cross-functional operating model, including governance, processes, and ways of working
• Translate strategic priorities into actionable roadmaps, aligning messaging, sequencing, and channel mix across the customer journey
• Identify and implement emerging technologies and digital innovations (e.g., personalization, modular content, AI-enabled orchestration, CRM) to enhance customer and patient experience
• Establish an Omnichannel Center of Excellence to drive best practices, education, and capability building
• Ensure omnichannel initiatives support both promotional and non-promotional objectives in a compliant manner
• Serve as a central connector across Marketing, Field, Market Access, Medical Affairs, Commercial Operations, Corporate Communications, and IT to enable coordinated planning and execution
• Partner with Market Access on patient, hub, eRx, and REMS experience innovation
• Collaborate with Legal and Compliance to ensure all digital and AI-enabled solutions meet internal governance and external regulatory requirements
• Oversee omnichannel planning, activation, and optimization across personal and non-personal channels
• Partner with Data & Analytics, IT, and Commercial Operations to ensure scalable, integrated execution
• Define KPIs and measurement frameworks to assess impact and optimize channel mix
• Drive continuous improvement through test-and-learn approaches and real-time optimization
• Serve as a member of the Digital Innovation Steering Committee
• Advance digital, AI, and patient experience capabilities as an internal thought leader
• Help shape AI governance, experimentation, and responsible deployment frameworks
• Monitor the digital and AI landscape to inform buy/build/partner decisions
• Champion change management and adoption of new tools, workflows, and scalable ways of working
• Establish a strategic approach to enabling and enhancing AI capabilities with internal and external partners