Executive Director, Translational Medicine & Pediatric Planning

Job description

Department: 107600 Clinical Pharmacology Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: The Executive Director, Translational Medicine and Pediatric Planning leads integrated translational and pediatric development strategy across the portfolio. This role connects disease biology, nonclinical findings, biomarkers, clinical pharmacology, and emerging clinical data to decisions on indication selection, dose, proof of mechanism, proof of concept, and development progression, with particular accountability for pediatric planning and execution. Working across multiple indications and therapeutic areas, the Executive Director partners with asset teams to develop and execute Pediatric Study Plans and Pediatric Investigation Plans, including waiver and deferral strategies, pediatric regulatory commitments, and associated clinical studies. The role requires strong scientific judgment, practical drug-development experience, and the ability to drive clear decisions in a matrixed organization. Responsibilities: Lead portfolio-level pediatric development strategy from candidate transition through registration, post-marketing commitments, indication expansion, and lifecycle management. Develop and execute pediatric plans across a range of indications and therapeutic areas, including Pediatric Study Plans, Pediatric Investigation Plans, waivers, deferrals, agreed measures, timelines, and pediatric exclusivity strategies, as applicable. Create integrated translational strategies that connect disease biology, target engagement, nonclinical pharmacology, biomarkers, clinical pharmacology, and clinical endpoints to development decisions. Evaluate adult, adolescent, pediatric, nonclinical, and real-world evidence to define opportunities for extrapolation, age-group sequencing, evidence bridging, and efficient pediatric development. Partner with Clinical Pharmacology and Pharmacometrics to establish pediatric starting doses, dose-escalation approaches, exposure targets, age-appropriate regimens, and model-informed development strategies. Work with CMC and device teams to address age-appropriate formulations, administration requirements, acceptability, supply, and technical dependencies that may affect pediatric plans. Lead or provide senior oversight of pediatric clinical study design and execution, including protocol concepts, endpoints, eligibility criteria, feasibility, enrollment strategy, country and site selection, and operational risk mitigation. Own the scientific and clinical content of pediatric regulatory deliverables and support meetings with FDA, EMA, and other health authorities, including responses to questions and negotiation of commitments. Maintain portfolio visibility to pediatric obligations, milestones, dependencies, decisions, and risks; identify issues early and drive practical mitigation or recovery plans with accountable owners. Provide clear recommendations to development teams and governance bodies on pediatric opportunity, scientific rationale, regulatory requirements, execution feasibility, timing, and investment. Guide biomarker, companion diagnostic, and translational evidence plans that support patient selection, pharmacodynamic assessment, mechanism confirmation, and proof-of-concept decisions. Contribute translational and pediatric expertise to early-development strategy, lead-indication selection, combination strategy, and adult-to-pediatric lifecycle planning. Build productive partnerships with pediatric investigators, key opinion leaders, cooperative groups, advocacy organizations, and external scientific experts to inform strategy and study feasibility. Partner closely with Research, Clinical Development, Regulatory, Clinical Operations, Clinical Pharmacology, Biometrics, Safety, CMC, Medical Affairs, and Program Management to align plans and execute cross-functional deliverables. Establish consistent planning standards, governance practices, templates, and training for pediatric and translational development; coach team members and contribute to functional capability building. Additional duties assigned as needed. Education/Experience Requirements: Advanced degree in medicine, pharmaceutical sciences, pharmacology, immunology, translational science, or a related discipline. Physician training through an MD or DO degree is preferred but not required. Equivalent combination of education and applicable job experience may be considered. 12+ years of relevant experience in clinical research or drug development required, including at least 7 years in the biotechnology or pharmaceutical industry. 5+ years of experience leading cross-functional clinical-development, translational, or pediatric strategy for global development programs. Demonstrated experience developing and executing pediatric plans across multiple indications, assets, or therapeutic areas, including direct work on PSPs, PIPs, waivers, deferrals, and health-authority interactions. Experience advancing programs through early and late clinical development, regulatory submission or approval, and post-marketing or lifecycle commitments. Experience in immunology is preferred. Experience in oncology, hematology, rare disease, gastroenterology, or other areas with complex pediatric development considerations is also valuable. Additional Skills/Experience: The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork. Driven, intelligent, passionate about making a difference for patients with rare diseases. Strong knowledge of pediatric drug-development requirements and incentives in the United States, European Union, and other major regions, including PREA, BPCA, PSPs, PIPs, waivers, deferrals, agreed measures, and pediatric post-marketing commitments. Expertise in translational medicine, including nonclinical-to-clinical integration, target engagement, biomarkers, proof of mechanism, proof of concept, and indication-selection strategy. Working knowledge of pediatric clinical pharmacology, dose extrapolation, pharmacometric approaches, age-related physiology, formulation considerations, and the use of adult data to support pediatric evidence generation. Ability to design feasible pediatric development programs that account for small populations, ethical constraints, recruitment challenges, age-appropriate endpoints, standard of care, and regional differences. Sound clinical and scientific judgment, with the ability to evaluate incomplete or conflicting evidence, state uncertainty clearly, and recommend timely decisions that protect patients and preserve development options. Excellent cross-functional leadership and influencing skills, including the confidence to challenge assumptions, resolve competing priorities, and secure alignment without relying on direct authority. Strong written and verbal communication skills, including preparation of regulatory