Pediatric Translational Medicine Executive Director (Remote)

Travere Therapeutics; Denver (CO); Hybrid; USD 246,000 - 332,000; Full time

Benefits offered by this job

Premium health

Retirement plans with employer match

Generous paid time off

Life insurance

Disability coverage

Job summary

Travere Therapeutics is seeking an Executive Director of Translational Medicine and Pediatric Planning to lead integrated pediatric development strategies across portfolio indications. The role connects disease biology, nonclinical data, biomarkers, and clinical pharmacology to inform dose, proof of mechanism, and development progression with pediatric focus.

The position requires strong scientific judgment, experience in pediatric development, and ability to drive decisions in a matrix

Qualifications

• Advanced degree in medicine, pharmaceutical sciences, pharmacology, immunology, translational science; MD/DO preferred but not required.
• 12+ years in clinical research or drug development; 7+ years in biotech/pharma.
• 5+ years leading cross-functional clinical-development or pediatric strategy.
• Experience developing PSPs, PIPs, waivers, deferrals, and regulatory interactions.
• Experience bringing programs through early and late development and regulatory submission.

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 and PIPs.
• Create translational strategies linking disease biology, biomarkers, nonclinical and clinical data to decisions.
• Evaluate adult, adolescent, pediatric, nonclinical, and real-world data for extrapolation and age-group sequencing.
• Partner with Clinical Pharmacology and Pharmacometrics for pediatric starting doses and dose-escalation strategies.
• Coordinate with CMC and device teams on age-appropriate formulations and administration requirements.
• Lead senior oversight of pediatric study design, endpoints, feasibility, country/site selection, and risk mitigation.
• Own scientific content of pediatric regulatory deliverables and interactions with FDA/EMA.
• Maintain visibility of pediatric obligations, milestones, dependencies, risks; drive mitigation plans.
• Provide recommendations on pediatric opportunity, regulatory requirements, feasibility, timing and investment.
• Guide biomarker and translational plans supporting patient selection and proof-of-concept decisions.
• Contribute to early-development strategy and cross-functional lifecycle planning.
• Build partnerships with pediatric investigators and regulators to inform strategy and study feasibility.
• Collaborate across departments to align plans and deliverables.
• Establish planning standards, governance, templates, and training for pediatric translational development.
• Additional duties as needed.

Job description

Travere Therapeutics is seeking an Executive Director of Translational Medicine and Pediatric Planning to lead integrated pediatric development strategies across portfolio indications. The role connects disease biology, nonclinical data, biomarkers, and clinical pharmacology to inform dose, proof of mechanism, and development progression with pediatric focus.

The position requires strong scientific judgment, experience in pediatric development, and ability to drive decisions in a matrix