Jobs at Travere Therapeutics

Supports pharmaceutical quality assurance activities for solid oral and biologic products, including validation and qualification documentation, change controls, manufacturing and laboratory investigations, CAPA, stability reports, regulatory data checks, and electronic QMS approvals. Collaborates with contract manufacturers and cross-functional teams to ensure cGMP and regulatory compliance. The role also contributes to technical projects, training, and quality-system improvements.

Develops and executes communications strategies for marketed products and pipeline assets in rare disease therapeutics. Translates complex scientific and clinical information into product messaging, press materials, thought leadership, digital content, and disease education. Partners with commercial, medical, regulatory, investor, and patient advocacy teams; supports media relations and executive preparation; manages agencies, budgets, timelines, and communications effectiveness.

Leads U.S. commercial strategy, marketing, and launch preparation for pegtibatinase in classical homocystinuria. Responsibilities include product positioning, segmentation, messaging, go-to-market planning, team leadership, agency management, cross-functional launch coordination, stakeholder engagement, KPI and budget management, and commercialization readiness across access, sales, medical affairs, patient services, and digital functions.

Leads commercial diligence for external business development opportunities and serves as Commercial Lead for selected acquired or internal pipeline assets. Evaluates markets, patient populations, competition, pricing, forecasts, and valuation inputs; integrates cross-functional insights into investment recommendations. Shapes asset strategy, target product profiles, evidence generation, indication prioritization, and commercialization roadmaps. Requires extensive biotechnology or pharmaceutical experience, strong scientific and quantitative skills, executive communication, and cross-functional leadership.

Provides pharmaceutical access and reimbursement expertise for FILSPARI across an assigned territory. Educates healthcare providers and sales teams on onboarding, REMS enrollment, prior authorizations, appeals, denials, and reimbursement processes. Manages escalated patient access cases by coordinating with hubs, specialty pharmacies, payers, and healthcare offices. Tracks case status, identifies regional reimbursement trends, develops business plans, and supports account education while maintaining HIPAA compliance.

Executes risk-based GMP and GDP audits across pharmaceutical, biologic, medical device, laboratory, logistics, and distribution suppliers. Evaluates compliance, audit findings, CAPA plans, supplier qualifications, quality events, and regulatory risks. Maintains supplier records and approved supplier lists, supports inspection readiness and quality systems using Veeva Vault, and contributes to procedures and continuous improvement. Requires cross-functional collaboration, strong technical writing, risk assessment, and 25–40% domestic and international travel.

Leads clinical data management for multiple development programs and trials, overseeing CROs, vendors, data quality, integrations, audits, inspections, database locks, regulatory compliance, and study deliverables. Develops timelines, data management plans, SOP inputs, and clinical data review processes. Provides subject matter expertise, mentors data management personnel, supports CDASH and SDTM standards, and manages EDC, IRT, ePRO, laboratory, and other data integrations. Requires independent leadership across cross-functional teams and approximately 10% travel.

Oversee clinical trial data management deliverables from study start-up through completion, ensuring accurate, complete, compliant data for publications and regulatory submissions. Lead CROs and vendors, manage data integrations across EDC, IRT, ePRO, laboratory, and other platforms, review data quality and discrepancies, support coding and user acceptance testing, develop data management documentation, plan database locks, maintain inspection readiness, and provide guidance to data management personnel.

Leads Global Medical Affairs strategic initiatives through portfolio coordination, project management, budget planning, forecasting, financial reporting, operational planning, and process improvement. Manages cross-functional programs, risks, dashboards, and KPIs while serving as the operational lead for departmental budgets. Owns Medical Affairs SharePoint and knowledge-management systems, improving document governance and collaboration. Partners with Finance and leadership on resource allocation, planning, and decision-making.

Lead analytical operations for a biologics product, managing method development, validation, transfer, specification setting, reference standards, document review, OOS/OOT investigations, and regulatory submission support while ensuring cGMP compliance across CDMOs/CROs.

Lead U.S. digital marketing and omnichannel activation for FILSPARI across HCP and patient/caregiver audiences. Set digital strategy, media mix, CRM/email, paid media, SEO/SEM, analytics, measurement, budgets, and agency partnerships. Ensure compliance with privacy, regulatory, accessibility, and governance standards. Coach Associate Director, collaborate cross-functionally, and drive performance optimization and resource allocation. Manage travel and on-site San Diego responsibilities.

Provide statistical support for HEOR, RWE, and Market Access activities including study design, analyses of clinical and real-world data (SDTM/ADaM, claims, EMR, registries), prepare analysis plans and documentation, collaborate with cross-functional teams and external vendors, review analytical work, and contribute to Biometrics SOPs and deliverables to support drug development and commercialization.

Leads R&D strategy and operations as Chief of Staff to the EVP and CMO. Drives portfolio planning, organizational effectiveness, governance, resource allocation, executive decision support, enterprise alignment, leadership communications, and administrative operations across R&D functions. Partners with Finance, People Success, and enterprise leadership on budgeting, change management, succession planning, strategic initiatives, and executive, board, investor, and scientific meeting preparation.

Lead development and execution of federal and state policy strategies for rare disease franchises. Provide strategic policy leadership, represent the company to external stakeholders, prepare executive briefing materials and policy analyses, coordinate cross-functional advocacy, engage state and federal policymakers, set goals and metrics, and support Corporate Affairs and patient advocacy efforts.

Lead organizational design, workforce capability planning, and change management to align talent and structure with business priorities. Partner with executives and People Success to drive succession planning, leadership development, transformation, and metrics that support scalable growth and improved organizational effectiveness.

Lead the Statistical Programming function supporting clinical development. Provide hands-on SAS programming and validation for analysis datasets, TLFs, submissions, and integrated summaries; manage programmers and vendors; develop SOPs, technical standards, and ensure quality and regulatory-compliant deliverables.

Lead competitive intelligence activities by monitoring scientific, clinical, regulatory, commercial, and financial landscapes; synthesize diverse sources into concise reports, trackers, and executive summaries; plan and execute congress intelligence; maintain knowledge repositories; partner with cross-functional teams to inform strategy; evaluate AI-enabled tools and manage external intelligence vendors.

Lead execution of CMC strategies for biologics, develop integrated project plans, manage risks and cross-functional alignment, support manufacturing, regulatory and supply readiness through clinical development and commercialization.

Provide corporate contract counsel for a biopharma company: draft, review, and negotiate a wide range of life‑science agreements; advise business partners on contract interpretation, compliance, and risk; optimize contracting policies and processes; and manage contract-related systems and cross‑functional stakeholder needs.

Lead translational pharmacology diligence and internal program support: evaluate mechanism, disease biology, pharmacology, biomarkers, and development feasibility for external assets and collaborations. Provide scientific leadership in cross-functional diligence, regulatory assessment, and translational strategy; engage external experts and CROs; identify risks, critical experiments, and development plans; mentor colleagues and support integration of selected opportunities into development.