Executive Director, Translational Medicine & Pediatric Planning

Travere • San Diego, CA

2d • 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 multiple 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 position requires strong scientific judgment, practical drug-development experience, and the ability to drive clear decisions in a matrixed organization. The role also establishes consistent planning standards, governance practices, templates, and training for pediatric and translational development, while coaching team members and contributing to functional capability building.

The position is listed as remote, but the posting states that no role is expected to be 100% remote and that all positions require the ability to perform face-to-face work with colleagues and/or onsite in San Diego. Domestic and international travel may be required as business needs require, approximately 10%.

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, state uncertainty clearly, 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 relying on 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 high standards for data quality, compliance, and follow-through.
• Ability to travel domestically and internationally as business needs require, approximately 10%.
• Ability to perform face-to-face work with colleagues and/or onsite in San Diego.
• Embody Travere’s core values of Courage, Community Spirit, Patient Focus, and Teamwork; be driven, intelligent, and passionate about making a difference for patients with rare diseases.

Nice To Haves

• Physician training through an MD or DO degree.
• Experience in immunology.
• Experience in oncology, hematology, rare disease, gastroenterology, or other areas with complex pediatric development considerations.
• Established relationships with, or demonstrated ability to work effectively with, pediatric investigators, academic experts, regulators, cooperative groups, and patient communities.

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 portfolio visibility to pediatric obligations, milestones, dependencies, decisions, and risks; identify issues early and drive mitigation or recovery plans with accountable owners.
• Provide recommendations to development teams and governance bodies 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.
• Travel domestically and internationally as business needs require, approximately 10%.
• Perform face-to-face work with colleagues and/or work onsite in San Diego as needed.

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.
• Cash compensation consisting of base pay and short-term incentive.
• Long-term incentive compensation in the form of company stock.

What This Job Offers

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