Vice President, Clinical Development (Rare Metabolic Disease)

Role Summary

Vice President, Clinical Development (non-renal) will be the project co-lead responsible for overall clinical, scientific, and strategic oversight for Travere’s rare metabolic development programs and clinical research projects across Phases 1-4. This will include an exciting, high-visibility, Phase 3 program in a rare metabolic disease and may include other therapeutic areas as the company expands its pipeline. This person should be a seasoned leader who can drive programs, key deliverables and execute cross-functionally in a matrix organization. This position will report to the SVP, Clinical Development and Clinical Pharmacology.

Responsibilities

• Co-lead for assigned development programs as part of the Program Strategy Team (PST) and represents the program to executive leadership and study team members
• Responsible for effectively communicating program goals, strategies, plans, issues and risks with team members, department heads, review boards, and the executive team
• Deep understanding of working with cross-functional team members to create clinical development plans, timelines, risk tradeoffs including regular engagement/presentations with regulatory agencies
• Responsible for leading the development of protocols and clinical/scientific strategy for Phase 1-4
• Understanding of the development and regulatory strategy from pre-IND to NDA/BLA and devices (Human Factor studies) to provide clinical and scientific insights
• Understanding and knowledge of the rare metabolic and genetic disease areas and future landscape to provide strategic input into future development needs, biometrics analyses, publications, and core presentations
• Partners with Biometrics to plan data entry, analysis, and interpretation for the PST and Medical Affairs colleagues
• Accountable for clinical portions of protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, and benefit/risk ratios
• Lead and mentor Clinical Development staff, consultants, and vendor medical monitor
• Establishes and maintains relationships with stakeholders i.e., alliance partners, external companies, investigators, and key opinion leaders
• Attend and present at investigator meetings and site initiation visits as applicable
• Works cross-functionally with medical affairs and prepares manuscripts, posters, and other scientific communications
• Goverance; represent programs and key decisions at cross-functional governance meetings
• Additional duties as needed

Qualifications

• M.D. or M.D./Ph.D. degree or equivalent required
• 12+ years of experience in clinical research including design and execution of clinical trials; 8+ years leadership experience
• Demonstrated ability to lead cross-functional teams in a matrix environment
• Metabolics/genetics and/or rare disease experience and NDA/BLA submissions strongly preferred

Additional Requirements

• Willingness to travel domestically and internationally (up to 25-30%)
• Ability to perform face-to-face work onsite in San Diego; not 100% remote