Lead, Translational Medicine & Pediatric Development

Travere Therapeutics; Washington (District of Columbia); Hybrid; USD 246.000 - 332.000; Vollzeit

Zusammenfassung

Travere Therapeutics seeks an Executive Director of Translational Medicine and Pediatric Planning to lead integrated pediatric development strategy across portfolio, aligning disease biology, nonclinical findings, biomarkers, and clinical data for decisions on indication selection and dosing.

You will partner with asset teams to develop Pediatric Study Plans and PSPs, drive regulatory commitments, and oversee global pediatric development across multiple indications with strong scientific

Qualifikationen

• 12+ years in clinical research or drug development
• 7+ years leading cross-functional clinical-development/translational/pediatric strategy
• Experience developing and executing pediatric plans across indications/assets
• Experience in PSPs, PIPs, waivers, deferrals, and health-authority interactions
• Immunology experience preferred; oncology/hematology/rare diseases value

Aufgaben

• Lead portfolio-level pediatric development strategy from candidate transition to registration and lifecycle management
• Develop and execute pediatric plans across indications and therapeutic areas
• Create integrated translational strategies connecting disease biology, biomarkers, and clinical endpoints
• Evaluate adult, adolescent, pediatric and real-world evidence for extrapolation and sequencing
• Partner with Clinical Pharmacology and Pharmacometrics to establish pediatric dosing and development strategies
• Coordinate with CMC and device teams on age-appropriate formulations and administration requirements
• Lead pediatric study design and execution including endpoints and site selection
• Prepare regulatory deliverables and support FDA/EMA interactions
• Maintain visibility of pediatric obligations, milestones, and risks with mitigation plans
• Provide strategic recommendations on pediatric opportunities and regulatory requirements

Kenntnisse

Leadership

Cross-functional collaboration

Regulatory strategy

Pediatric drug development

Strategic planning

Ausbildung

Advanced degree in medicine or related field

MD/DO preferable

Jobbeschreibung

Travere Therapeutics seeks an Executive Director of Translational Medicine and Pediatric Planning to lead integrated pediatric development strategy across portfolio, aligning disease biology, nonclinical findings, biomarkers, and clinical data for decisions on indication selection and dosing.

You will partner with asset teams to develop Pediatric Study Plans and PSPs, drive regulatory commitments, and oversee global pediatric development across multiple indications with strong scientific