Executive Director, Translational Medicine & Pediatric Planning

Travere Therapeutics • San Diego, CA

4d • $246,000 - $332,000 • Remote

About The Position

The Executive Director, Translational Medicine and Pediatric Planning leads integrated translational and pediatric development strategy across Travere Therapeutics’ portfolio. The role connects disease biology, nonclinical findings, biomarkers, clinical pharmacology, and emerging clinical data to decisions about indication selection, dose, proof of mechanism, proof of concept, and development progression, with particular accountability for pediatric planning and execution.

Working across indications and therapeutic areas, the Executive Director partners with asset teams to develop and execute Pediatric Study Plans and Pediatric Investigation Plans, including waiver and deferral strategies, pediatric regulatory commitments, and associated clinical studies. The role calls for strong scientific judgment, practical drug-development experience, and the ability to drive clear decisions in a matrixed organization.

The position works closely with research, clinical development, regulatory, clinical operations, clinical pharmacology, biometrics, safety, CMC, medical affairs, and program management. It also contributes to governance, planning standards, training, and functional capability building. Travel domestically and internationally may be required at approximately 10%. The posting states that no role is expected to be 100% remote and that all positions have an essential function of face-to-face work with colleagues and/or onsite in San Diego.

Requirements

• Advanced degree in medicine, pharmaceutical sciences, pharmacology, immunology, translational science, or a related discipline; an equivalent combination of education and applicable job experience may be considered.
• At least 12 years of relevant experience in clinical research or drug development, including at least 7 years in the biotechnology or pharmaceutical industry.
• At least 5 years of experience leading cross-functional clinical-development, translational, or pediatric strategy for global development programs.
• Demonstrated experience developing and executing pediatric plans across multiple indications, assets, or therapeutic areas, including direct work on PSPs, PIPs, waivers, deferrals, and health-authority interactions.
• Experience advancing programs through early and late clinical development, regulatory submission or approval, and post-marketing or lifecycle commitments.
• Strong knowledge of pediatric drug-development requirements and incentives in the United States, European Union, and other major regions, including PREA, BPCA, PSPs, PIPs, waivers, deferrals, agreed measures, and pediatric post-marketing commitments.
• Expertise in translational medicine, including nonclinical-to-clinical integration, target engagement, biomarkers, proof of mechanism, proof of concept, and indication-selection strategy.
• Working knowledge of pediatric clinical pharmacology, dose extrapolation, pharmacometric approaches, age-related physiology, formulation considerations, and use of adult data to support pediatric evidence generation.
• Ability to design feasible pediatric development programs accounting for small populations, ethical constraints, recruitment challenges, age-appropriate endpoints, standard of care, and regional differences.
• Sound clinical and scientific judgment, including the ability to evaluate incomplete or conflicting evidence, communicate uncertainty, and recommend timely decisions that protect patients and preserve development options.
• Excellent cross-functional leadership and influencing skills, including the ability to challenge assumptions, resolve competing priorities, and secure alignment without direct authority.
• Strong written and verbal communication skills, including preparation of regulatory documents, governance presentations, protocols, development plans, and concise recommendations for senior leaders.
• Ability to manage multiple programs, external partners, timelines, and competing priorities while maintaining standards for data quality, compliance, and follow-through.
• Ability to travel domestically and internationally as business needs require, approximately 10%.

Nice To Haves

• Physician training through an MD or DO degree is preferred but not required.
• Experience in immunology is preferred.
• Experience in oncology, hematology, rare disease, gastroenterology, or other areas with complex pediatric development considerations is valuable.
• Established relationships with, or demonstrated ability to work effectively with, pediatric investigators, academic experts, regulators, cooperative groups, and patient communities.
• Alignment with Travere’s core values: Courage, Community Spirit, Patient Focus, and Teamwork.

Responsibilities

• Lead portfolio-level pediatric development strategy from candidate transition through registration, post-marketing commitments, indication expansion, and lifecycle management.
• Develop and execute pediatric plans across indications and therapeutic areas, including Pediatric Study Plans, Pediatric Investigation Plans, waivers, deferrals, agreed measures, timelines, and pediatric exclusivity strategies, as applicable.
• Create integrated translational strategies connecting disease biology, target engagement, nonclinical pharmacology, biomarkers, clinical pharmacology, and clinical endpoints to development decisions.
• Evaluate adult, adolescent, pediatric, nonclinical, and real-world evidence to define opportunities for extrapolation, age-group sequencing, evidence bridging, and efficient pediatric development.
• Partner with Clinical Pharmacology and Pharmacometrics to establish pediatric starting doses, dose-escalation approaches, exposure targets, age-appropriate regimens, and model-informed development strategies.
• Work with CMC and device teams on age-appropriate formulations, administration requirements, acceptability, supply, and technical dependencies affecting pediatric plans.
• Lead or provide senior oversight of pediatric clinical study design and execution, including protocol concepts, endpoints, eligibility criteria, feasibility, enrollment strategy, country and site selection, and operational risk mitigation.
• Own the scientific and clinical content of pediatric regulatory deliverables and support meetings with FDA, EMA, and other health authorities, including responses to questions and negotiation of commitments.
• Maintain visibility into pediatric obligations, milestones, dependencies, decisions, and risks across the portfolio; identify issues early and drive mitigation or recovery plans with accountable owners.
• Provide development teams and governance bodies with recommendations on pediatric opportunity, scientific rationale, regulatory requirements, execution feasibility, timing, and investment.
• Guide biomarker, companion diagnostic, and translational evidence plans supporting patient selection, pharmacodynamic assessment, mechanism confirmation, and proof-of-concept decisions.
• Contribute translational and pediatric expertise to early-development strategy, lead-indication selection, combination strategy, and adult-to-pediatric lifecycle planning.
• Build partnerships with pediatric investigators, key opinion leaders, cooperative groups, advocacy organizations, and external scientific experts to inform strategy and study feasibility.
• Partner with Research, Clinical Development, Regulatory, Clinical Operations, Clinical Pharmacology, Biometrics, Safety, CMC, Medical Affairs, and Program Management to align plans and execute cross-functional deliverables.
• Establish planning standards, governance practices, templates, and training for pediatric and translational development; coach team members and contribute to functional capability building.
• Perform additional duties as assigned.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance.
• Disability benefits.
• Retirement plans with employer match.
• Generous paid time off.
• Base pay and short-term incentive cash compensation.
• Long-term incentive compensation in company stock.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive