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.

This accomplished and experienced clinical leader will work collaboratively with all functions including co-leading the development Program Strategy Team (PST) to develop and deliver a clinical development strategy tailored to the disease that is efficient and of high scientific quality. Additional responsibilities include developing relationships with leading key opinion leaders, acting as subject matter expert for additional programs, providing medical support as needed for clinical trials, marketed products, pharmacovigilance, as well as providing medical/scientific expertise as needed for business development efforts.

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 is critical
• 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 as part of the PST
• Understanding and knowledge of the rare metabolic and genetic disease areas as well as the future landscape and treatment paradigm in order 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 to foster a high-performance culture within the Clinical Development department
• Proactively 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 and conducts presentations at scientific meetings
• Understanding of governance and ability to represent the programs and key decisions at cross-functional governance meetings
• Additional duties assigned as needed

Education/Experience Requirements

• M.D. or M.D./Ph.D. degree or equivalent required. Equivalent combination of education and applicable job experience may be considered
• 12+ years of experience in clinical research including the design and execution of clinical trials, preferably within a pharmaceutical or biotech environment although time spent in relevant high caliber academic clinical research will be counted towards the total; 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 is strongly preferred

Additional Skills/Experience/Requirements

• The ideal candidate will embody Travere‚Äôs core values: Courage, Community Spirit, Patient Focus and Teamwork
• Driven, intelligent, passionate about making a difference for patients with rare diseases
• Strong interpersonal and organizational skills and excellent verbal and written communication skills
• Experiences with devices and human factors studies preferred
• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
• Demonstrated ability to review, interpret and present complex scientific data
• Well-organized with the ability to multi-task, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment
• Excellent collaboration skills with strong attention to detail and the ability to manage complexity and challenges
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
• Ability to travel domestically and internationally (up to 25 to 30%)
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.