Travere Therapeutics

Medical Director

• Provide management and support for ongoing and future nephrology development and life-cycle activities for clinical programs
• Assist in the design and implementation of clinical studies, including human pharmacology studies, and data analyses
• Assist in reporting clinical trial safety and efficacy data
• Collaborate with cross-functional multidisciplinary study teams to ensure Good Clinical Practices are followed
• Lead writing of clinical and data analysis reports, slide presentations, ClinicalTrials.gov summaries, and related materials
• Contribute to clinical, scientific, and mechanism-of-action sections of INDs, NDAs, and BLAs
• Prepare protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and responses to regulator information requests
• Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders
• Prepare manuscripts for scientific and medical journals
• Prepare and present at scientific meetings

Director, Clinical Science

Compliance

• Develop and implement global CMC regulatory strategies for clinical development, registration, commercialization, and lifecycle management of small molecule products
• Serve as CMC Regulatory lead on cross-functional program teams
• Provide strategic regulatory guidance throughout product development and commercialization
• Partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management
• Assess regulatory risks, develop mitigation strategies, and provide regulatory recommendations
• Support products from IND through NDA approval and post-approval lifecycle management
• Lead preparation, review, and submission of global CMC filings, including INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, variations, annual reports, and Health Authority responses
• Author and review Module 2 and Module 3 CMC documentation
• Coordinate cross-functional contributions and ensure regional regulatory compliance
• Represent CMC Regulatory Affairs in Health Authority meetings and responses
• Support inspection readiness and regulatory assessments related to manufacturing, quality systems, and product quality
• Develop filing strategies for post-approval CMC changes
• Guide formulation development, process development, scale-up, technology transfer, process validation, and commercial manufacturing
• Evaluate regulatory impacts of APIs, excipients, formulations, manufacturing processes, packaging systems, and manufacturing sites
• Provide oversight for analytical method development, validation, specifications, and stability programs
• Contribute to assessments of CMAs, CPPs, CQAs, control strategies, and pharmaceutical development
• Support combination product or biologic product regulatory activities when applicable

Associate Director, CMC Regulatory Affairs – Small Molecules

Technical Writer

• Lead planning, authoring, and delivery of CMC content for regulatory submissions such as BLAs, including CTD Module 2 summaries and Module 3 sections
• Translate complex technical data into clear, concise, accurate, regulator-ready narratives
• Develop document strategies, content plans, timelines, templates, and authoring standards for CMC submissions
• Author and coordinate sections covering drug substance and drug product manufacturing, process development, characterization, validation, control strategies, fermentation, purification, specifications, analytical procedures, formulation, lyophilization, container closure, stability, comparability, and lifecycle changes
• Ensure consistency across Module 3 sections and alignment with regulatory strategy, source reports, and supporting data
• Lead cross-functional authoring and decision-making forums
• Reconcile differing technical perspectives and establish key regulatory messages
• Drive timely resolution of technical and content gaps
• Identify submission risks, data gaps, inconsistencies, and potential regulatory questions
• Manage document reviews, comment resolution, version control, and approval workflows
• Support responses to FDA information requests and other regulatory questions during BLA review
• Collaborate with internal teams, contract manufacturers, testing laboratories, consultants, and external partners
• Prepare PowerPoint presentations for governance meetings, regulatory interactions, technical reviews, and executive updates
• Establish sustainable CMC authoring best practices
• Perform additional duties as needed

Director, Biologics CMC Technical Writing

Director

• Direct and coordinate manufacturing activities at CMOs for commercial drug products to ensure uninterrupted market supply
• Establish and maintain manufacturing schedules based on internal sales forecasts and Sales & Operations Planning decisions
• Assess capacity, inventory, and supply risks
• Lead development of mitigation and contingency plans
• Verify suitability, qualification, and validation of processes at CMOs for drug product
• Provide manufacturing support and troubleshooting on internal and external project teams
• Maintain current knowledge of US and EU GMPs and applicable regulatory guidance
• Represent commercial manufacturing for technical due diligence, CMO selection, qualification, contracting support, and manufacturing-network strategy
• Author and edit technical reports on manufacturing-related subjects
• Assist management during regulatory inspections and internal and external audits
• Assist with development of CMC sections of regulatory submissions
• Provide recommendations to senior management regarding capacity, resources, risk, and external manufacturing strategy
• Perform additional duties as assigned

Associate Director, Commercial Manufacturing – Packaging

Operations

• Develop, execute, and provide ongoing oversight of the CMC strategy for a diverse portfolio of small molecules in development
• Ensure test articles and study drugs are developed and manufactured on time, within budget, and within scope
• Lead external manufacturing partners
• Collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management
• Identify and mitigate CMC risks
• Achieve development, regulatory, and commercialization milestones
• Provide strategic and technical leadership for technology transfer, scale-up, validation, and cGMP manufacturing activities across Phase I–III clinical development and commercial products
• Lead selection, qualification, governance, and performance management of CMOs, collaboration partners, and external technical service providers
• Oversee chemical development of new drug candidates
• Review regulatory filings, specifications, change controls, and Master Batch Records
• Provide technical oversight of CMOs developing, validating, transferring, and maintaining manufacturing and analytical methods for APIs and finished dosage forms
• Support regulatory inspections, partner audits, and ongoing compliance with cGMP requirements and global regulatory expectations
• Provide technical leadership and mentorship to colleagues and cross-functional project teams
• Author and edit CMC sections of regulatory submissions as required
• Perform additional duties as assigned

Associate Director, Technical Operations

Customer Success Manager

• Operate through a shared product and delivery model with Commercial Systems & Analytics
• Align technology, data, reporting, and analytics ownership with BTS accountabilities for architecture, integration, security, scalability, vendor management, and lifecycle planning
• Translate business, product, and data strategies into product plans, prioritized backlogs, requirements, solution designs, estimates, release plans, and operating practices
• Provide BTS product and technical leadership for Veeva, Salesforce CRM, PromoMats, content management, marketing automation, digital engagement, medical communications, consent and preference management, analytics enablement, APIs, and integrations
• Advance customer data capabilities across HCP, HCO, payer, specialty pharmacy, hub, patient services, affiliate, and related domains
• Align data stewardship, quality, access, consent, reporting, analytics, and Customer 360 needs with shared data models, pipelines, governance, and reusable data products
• Translate customer journeys, omnichannel, content, channel, and experimentation priorities into scalable platform capabilities
• Evaluate and deliver governed AI-enabled use cases with AI Strategy & Engineering
• Lead delivery and operations from discovery through deployment, stabilization, support, and continuous improvement
• Coordinate releases, incidents, problems, service levels, vendors, documentation, and lifecycle plans for jointly operated platforms
• Embed privacy, security, data integrity, validation, assurance, and promotional and medical compliance into solutions and operating practices
• Drive process improvement, organizational readiness, change management, training, adoption, and benefits realization
• Establish shared measures for user experience, field effectiveness, adoption, data quality, reliability, cycle time, and business value
• Guide and coach internal and external technical contributors

Associate Director, Customer Engagement Platforms, Data

• Build and strengthen strategic relationships with Commercial and Global Medical Affairs leaders
• Translate business, launch, and scientific priorities into product strategies, capability investments, and measurable outcomes
• Define the future-state digital ecosystem and lead product vision, roadmaps, investment priorities, business cases, and tradeoff decisions
• Partner with Digital Innovation & Strategy to provide integrated business and technology support
• Lead functional demand and portfolio governance
• Partner on enterprise portfolio processes, standards, investment tracking, executive reporting, and escalation
• Develop a lean, product-oriented team while working hands-on across discovery, business process design, architecture, requirements, vendor selection, configuration, integration, testing, deployment, training, and problem resolution
• Own delivery, operations, and continuous improvement of Commercial and Global Medical Affairs product capabilities and platforms, including Veeva, Salesforce CRM, PromoMats, MedComms, master and consent data, field and omnichannel enablement, market access, patient services, medical information, KOL engagement, analytics, and integrations
• Establish metrics for value, adoption, data quality, reliability, and risk
• Drive process improvement, organizational readiness, change management, training, adoption, scaling, and benefits realization
• Embed security, privacy, data integrity, records retention, validation and assurance, and promotional and medical compliance into solutions
• Support audits and timely remediation
• Recruit, coach, and develop employees
• Lead systems integrators, managed service providers, and consultants
• Manage budgets, contracts, service levels, delivery risk, and knowledge transfer

Senior Director, Enterprise Technology & Solutions

• Provide strategic and tactical support for nephrology programs under the supervision of the Executive Director, Global Medical Affairs, Nephrology
• Lead interactions and collaboration with external experts
• Develop and deliver scientific engagement activities, including advisory boards
• Support medical-led scientific meetings, such as the RKD Scientific Summit
• Collaborate with the scientific communication team on scientific messaging and content
• Support publication planning, medical education activities, and congress planning
• Collaborate with field medical partners on external expert interactions, evidence generation activities, and team training
• Lead Medical Affairs competitive intelligence activities and communicate actionable recommendations
• Represent Medical Affairs at Medical Review Committee and Promotional Review Committee meetings
• Support the Executive Medical Director with commercial and payor-related activities
• Support annual Medical Strategic planning and life-cycle management plans
• Partner with Strategy & Operations to ensure effective processes and systems for the Nephrology Therapeutic Area
• Manage vendors and budgets to drive corporate efficiency
• Perform additional duties as assigned

Medical Director – Global Medical Affairs, Nephrology

Manager

• Serve as the subject matter expert on access and reimbursement for FILSPARI (Sparsentan)
• Provide education and case-specific support to HCPs, sales force, and other internal and external stakeholders within the assigned geography
• Manage patient access and reimbursement support throughout the FILSPARI onboarding process
• Guide offices through Patient Start Form submission, REMS enrollment, prior authorizations, appeals, and reimbursement
• Monitor cases as they progress through onboarding
• Identify and resolve complex patient access issues across the Hub, HCP offices, field team, specialty pharmacies, and REMS administrator
• Assist with incomplete PSFs and REMS enrollment forms and coordinate missing information
• Support resolution of prior authorization issues, appeals, denials, letters of medical necessity, and REMS requirements
• Communicate case challenges, solutions, next steps, and ownership to reimbursement stakeholders
• Obtain case-status updates and maintain daily logs and notes in the standardized platform
• Lead weekly case-status meetings with sales force and sales leadership
• Educate the sales force on pharmaceutical reimbursement complexities and payer claim approval requirements
• Coordinate with Hub, specialty pharmacies, and REMS administrator stakeholders to move cases forward
• Operate in compliance with HIPAA and program guidelines
• Monitor regional and local access landscapes, payer trends, and healthcare changes
• Identify reimbursement barriers and create quarterly business plans to address them
• Develop and execute HCP office education strategies with sales counterparts

Access & Reimbursement Manager

Communications

• Develop and execute integrated communications strategies for marketed products and pipeline assets, focusing on FILSPARI and programs in classical HCU and rare kidney disease
• Create communications plans supporting commercial priorities and key product milestones, including clinical updates, data presentations and publications, regulatory events, medical congresses and lifecycle management initiatives
• Lead development of product communication materials, including press releases, FAQs, product messaging guides, thought leadership content and digital assets
• Partner across R&D, Medical Affairs, Regulatory Affairs, Commercial, Patient Advocacy, Investor Relations and Corporate Communications to align messaging and support disease education, thought leadership and future market-shaping objectives
• Support media relations and digital and social content related to products, pipeline and disease areas
• Prepare executives and subject-matter experts for external engagements
• Manage agency partners, project timelines and budgets
• Measure communications effectiveness to inform future strategies
• Contribute to broader corporate reputation and storytelling initiatives