Remote Lead, Translational Medicine & Pediatric Development

Travere Therapeutics; Providence (RI); On-site; USD 246,000 - 332,000; Full time

Benefits offered by this job

Health insurance

Job summary

Travere Therapeutics is seeking an Executive Director of Translational Medicine and Pediatric Planning to lead pediatric development strategy across multiple indications, coordinating disease biology, nonclinical data, biomarkers, and clinical pharmacology to guide decisions on dose, proof of concept, and progression.

The role partners with asset teams to develop Pediatric Study Plans and Investigations Plans, including waivers and deferrals, ensuring regulatory commitments are met with

Qualifications

• 12+ years in clinical research or drug development.
• 7+ years in biotech/pharmaceutical industry.
• 5+ years leading cross-functional clinical-development or pediatric strategy.
• Experience with PSPs, PIPs, waivers/deferrals and health-authority interactions.
• Immunology experience preferred; oncology/rare disease exposure valuable.

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 and timelines.
• Create translational strategies linking biology, biomarkers, nonclinical data, clinical pharmacology and endpoints.
• Evaluate adult to pediatric extrapolation opportunities and evidence bridging.
• Partner with Clinical Pharmacology and Pharmacometrics for pediatric dosing strategies.
• Work with CMC and device teams on age-appropriate formulations and administration requirements.
• Oversee pediatric study design, endpoints, eligibility criteria, enrollment strategy and site selection.
• Prepare regulatory deliverables and support FDA/EMA interactions; respond to questions.

Skills

Leadership

Regulatory knowledge

Pediatric development

Translational medicine

Communication

Stakeholder management

Education

MD/DO preferred

Advanced biomedical degree

Job description

Travere Therapeutics is seeking an Executive Director of Translational Medicine and Pediatric Planning to lead pediatric development strategy across multiple indications, coordinating disease biology, nonclinical data, biomarkers, and clinical pharmacology to guide decisions on dose, proof of concept, and progression.

The role partners with asset teams to develop Pediatric Study Plans and Investigations Plans, including waivers and deferrals, ensuring regulatory commitments are met with