Vice President, Clinical Development (Rare Metabolic Disease)

Role Summary

The 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. The role involves co-leading the development Program Strategy Team, developing relationships with key opinion leaders, and providing medical/scientific expertise for trials, marketed products, pharmacovigilance, and business development efforts. Location: San Diego, USA (Remote).

Responsibilities

• Co-lead for assigned development programs as part of the Program Strategy Team (PST) and represent 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
• Collaborate with cross-functional teams to create clinical development plans, timelines, and risk tradeoffs, including regular engagements/presentations with regulatory agencies
• Lead the development of protocols and clinical/scientific strategy for Phase 1-4
• Provide clinical and scientific insights on development/regulatory strategy (from pre-IND to NDA/BLA) and devices (Human Factor studies) as part of the PST
• Apply knowledge of rare metabolic/genetic diseases and future landscape to inform development needs, biometrics analyses, publications, and core presentations
• Partner with Biometrics to plan data entry, analysis, and interpretation for the PST and Medical Affairs colleagues
• Own clinical portions of protocols, investigator brochures, medical reports, efficacy/safety summaries, scientific rationales, and benefit/risk assessments
• Lead and mentor Clinical Development staff, consultants, and vendor medical monitors to foster a high-performance culture
• Establish and maintain relationships with stakeholders such as alliance partners, external companies, investigators, and key opinion leaders
• Attend and present at investigator meetings and site initiation visits as applicable
• Collaborate with medical affairs to prepare manuscripts, posters, and other scientific communications; present at scientific meetings
• Represent programs at cross-functional governance meetings
• Additional duties as needed

Qualifications

• Required: M.D. or M.D./Ph.D. degree or equivalent; 12+ years of experience in clinical research including design and execution of trials; 8+ years of leadership experience; experience leading cross-functional teams in a matrix environment
• Preferred: Metabolics/genetics and/or rare disease experience; NDA/BLA submissions strongly preferred
• Required: Ability to work effectively in a multidisciplinary team and communicate complex scientific data
• Preferred: Experience with devices and human factors studies
• Required: Demonstrated ability to develop and implement clinical development plans and to interact with regulatory agencies

Education

• M.D. or M.D./Ph.D. degree or equivalent required