Head of Translational Medicine & Pediatric Development

Travere Therapeutics; Columbus (OH); Remote; USD 246,000 - 332,000; Full time

Benefits offered by this job

Premium health benefits

Financial planning and retirement with

Generous paid time off

Job summary

Travere Therapeutics in San Diego is seeking an Executive Director, Translational Medicine and Pediatric Planning to lead integrated pediatric development strategy across the portfolio, connecting disease biology, nonclinical data, biomarkers, and clinical pharmacology to key development decisions.

The role partners with asset teams to develop PSPs and PSPs/PIPs, waivers, and regulatory commitments, guiding dose selection, age-appropriate regimens, and strategy for global development, with

Qualifications

• Advanced degree in medicine or pharmaceutical sciences; MD/DO preferred.
• 12+ years in clinical research or drug development; 7+ years in biotech/pharma.
• 5+ years leading cross-functional clinical development or pediatric strategy.
• Experience with PSPs, PIPs, waivers/deferrals and regulatory interactions.
• Willingness to travel ~10% and work onsite in San Diego as needed.

Responsibilities

• Lead portfolio-level pediatric development strategy from candidate transition through registration.
• Develop PSPs, PIPs, waivers and deferrals for multiple indications.
• Create integrated translational strategies linking biology to decisions.
• Evaluate adult, adolescent, pediatric, nonclinical, and real-world evidence for extrapolation.
• Define starting doses and dose-escalation approaches with PK/PD input.
• Collaborate with FDA/EMA and health authorities on updates and responses.

Skills

Cross-functional leadership

Regulatory documentation

Strategic planning

Education

Advanced degree in medicine or pharmaceutical sciences

MD or DO degree preferred

Job description

Travere Therapeutics in San Diego is seeking an Executive Director, Translational Medicine and Pediatric Planning to lead integrated pediatric development strategy across the portfolio, connecting disease biology, nonclinical data, biomarkers, and clinical pharmacology to key development decisions.

The role partners with asset teams to develop PSPs and PSPs/PIPs, waivers, and regulatory commitments, guiding dose selection, age-appropriate regimens, and strategy for global development, with