Executive Director, Pediatric Translational Medicine Strategy

Travere Therapeutics; Boston (MA); Hybrid; USD 246,000 - 332,000; Full time

Job summary

Travere Therapeutics in San Diego, CA is seeking an Executive Director, Translational Medicine and Pediatric Planning to lead integrated pediatric development strategy across portfolio. This role connects disease biology, nonclinical findings, biomarkers, and clinical data to decisions on indication, dose, and progression.

Working across indications, the role partners with asset teams to develop Pediatric Study Plans and Pediatric Investigation Plans, including regulatory waivers and deferrals,

Qualifications

• Advanced degree in medicine or pharmaceutical sciences; MD/DO preferred but not required.
• 12+ years of clinical research or drug development experience.
• Minimum 7 years leading cross-functional clinical development or pediatric strategy.
• Experience developing pediatric plans across indications and PSPs/PIPs.
• Experience with regulatory submissions and health authority interactions.
• Ability to travel ~10% domestically and internationally.

Responsibilities

• Lead portfolio-level pediatric development strategy from candidate transition through registration and lifecycle management.
• Develop and execute pediatric plans across indications and therapeutic areas, including PSPs, PIPs, waivers, deferrals.
• Create integrated translational strategies linking biology, biomarkers, and clinical endpoints to decisions.
• Evaluate adult, adolescent, pediatric and real-world evidence for extrapolation and sequencing.
• Partner with Clinical Pharmacology and Pharmacometrics to establish pediatric dosing strategies.
• Coordinate with CMC and device teams on age-appropriate formulations and administration needs.
• Lead or oversee pediatric study design, endpoints, eligibility, feasibility, enrollment strategy, site selection.
• Own pediatric regulatory deliverables and support FDA/EMA interactions.
• Maintain portfolio visibility of obligations, milestones, and risks with mitigation plans.
• Provide recommendations on pediatric opportunities and regulatory requirements.
• Guide translational evidence plans to support patient selection and proof-of-concept.

Skills

Cross-functional leadership

Pediatric development knowledge

Regulatory strategy

Scientific judgment

Regulatory submissions

Education

Advanced degree in medicine or pharmaceutical sciences

Job description

Travere Therapeutics in San Diego, CA is seeking an Executive Director, Translational Medicine and Pediatric Planning to lead integrated pediatric development strategy across portfolio. This role connects disease biology, nonclinical findings, biomarkers, and clinical data to decisions on indication, dose, and progression.

Working across indications, the role partners with asset teams to develop Pediatric Study Plans and Pediatric Investigation Plans, including regulatory waivers and deferrals,