Executive Director, Translational Medicine – Pediatric Planning

Travere Therapeutics

. Lead portfolio-level pediatric development strategy from candidate transition through registration, post-marketing commitments, indication expansion, and lifecycle management .

Posted 10/15/2026full-timeSan Diego • California • United StatesLead💰 $246,000 - $332,000 per yearWebsite

About the role

Key responsibilities & impact

Lead portfolio-level pediatric development strategy from candidate transition through registration, post-marketing commitments, indication expansion, and lifecycle management
Develop and execute Pediatric Study Plans, Pediatric Investigation Plans, waivers, deferrals, agreed measures, timelines, and pediatric exclusivity strategies
Create integrated translational strategies connecting disease biology, target engagement, nonclinical pharmacology, biomarkers, clinical pharmacology, and clinical endpoints to development decisions
Evaluate adult, adolescent, pediatric, nonclinical, and real-world evidence for extrapolation, age-group sequencing, evidence bridging, and efficient pediatric development
Partner with Clinical Pharmacology and Pharmacometrics on pediatric starting doses, dose escalation, exposure targets, age-appropriate regimens, and model-informed development
Work with CMC and device teams on age-appropriate formulations, administration, acceptability, supply, and technical dependencies
Lead or oversee pediatric clinical study design and execution, including protocols, endpoints, eligibility, feasibility, enrollment, country and site selection, and operational risk mitigation
Own scientific and clinical content of pediatric regulatory deliverables and support FDA, EMA, and other health-authority meetings
Maintain visibility into pediatric obligations, milestones, dependencies, decisions, and risks; drive mitigation or recovery plans
Provide recommendations to development teams and governance bodies on pediatric opportunity, scientific rationale, regulatory requirements, feasibility, timing, and investment
Guide biomarker, companion diagnostic, and translational evidence plans supporting 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 partnerships with pediatric investigators, key opinion leaders, cooperative groups, advocacy organizations, and external scientific experts
Partner with Research, Clinical Development, Regulatory, Clinical Operations, Clinical Pharmacology, Biometrics, Safety, CMC, Medical Affairs, and Program Management
Establish planning standards, governance practices, templates, and training; coach team members and contribute to capability building
Perform additional duties as assigned

Requirements

What you’ll need

Advanced degree in medicine, pharmaceutical sciences, pharmacology, immunology, translational science, or a related discipline
Equivalent combination of education and applicable job experience may be considered
12+ years of relevant experience in clinical research or drug development, 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 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
Strong knowledge of pediatric drug-development requirements and incentives in the United States, European Union, and other major regions
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 adult data use for pediatric evidence generation
Ability to design feasible pediatric development programs accounting for small populations, ethical constraints, recruitment challenges, age-appropriate endpoints, standard of care, and regional differences
Strong written and verbal communication skills, including regulatory documents, governance presentations, protocols, development plans, and senior-leader recommendations
Ability to manage multiple programs, external partners, timelines, and competing priorities while maintaining data quality, compliance, and follow-through
Ability to travel domestically and internationally as business needs require, approximately 10%
Ability to perform face-to-face work with colleagues and/or onsite in San Diego

Benefits

Comp & perks

Premium health, financial, work-life and well-being offerings for eligible employees and dependents
Wellness and employee support programs
Life insurance
Disability benefits
Retirement plans with employer match
Generous paid time off
Short-term incentive compensation
Long-term incentive compensation through company stock