Executive Director, Translational Medicine & Pediatric Planning

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.

Main…