Department:106750 Clinical Dev - Non-Renal

Location:USA- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary:

The Vice President of Clinical Development, as a strategic partner to the Chief Medical Officer, will provide strategic planning and execution of the rare nephrology and metabolic programs and will oversee the cross-functional Project Strategy Teams comprised of Clinical Development, Clinical Operations, Regulatory, CMC, Med Affairs, Commercial and Project Management. This position will be responsible for establishing and executing the global strategy for the development, approval and commercialization across Travere's pipeline and potential new programs. This person is expected to have a wide range of clinical development leadership and expertise in nephrology and rare disease for due diligence and clinical development strategy across the lifecycle of therapeutics from pre-IND to commercialization as well as small molecule to biologics. This person should be a seasoned leader who can drive programs, key deliverables and execute cross-functionally in a matrix organization.

Responsibilities:

Provide clinical leadership, guidance and strategy to Travere's programs. Manage the overall clinical development for Travere's programs, ensuring that clinical and regulatory milestones are met.

Guide the team through the development and/or update of the global strategic plan that lays out a pathway for successful development and commercial approval

Have a deep understanding and knowledge of Travere's core disease areas (rare nephrology + metabolic) 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.

Provide scientific oversight, foster debate and solicit expert input (internal and external) on important development choices; lay out alternatives, analyze key risks and implications of choices, and drive team to agreement on strategic, development, regulatory & operational recommend

Responsible for effectively communicating program goals, strategies, plans, issues and risks with team members, department heads, review boards, the executive team and the board of directors.

Regulatory strategy and FDA engagement is a key component of this role and deep understanding of creating clinical development plans, timelines, risk tradeoffs including regular engagement/presentations with regulatory agencies is critical.

Directly responsible for managing clinical development (renal and metabolic) including managing and mentoring and leading clin dev physicians, clinical scientists and clinical pharmacology.

Work with the team to develop aggressive but realistic Project Team goals, plans, timelines and budgets and with oversight of the program execution.

Ensure appropriate communications channels are aintained and reporting schedules adhered to.

Strategic engagement across multiple department heads including biometrics, regulatory, clinical operations, and medical affairs to ensure dissemination of information and strategic alignment across programs.

Cross collaboration with therapeutic leaders in medical affairs to contribute scientifically to publication strategy, congress planning, scientific communication and messaging, and KOL engagement.

Cross collaboration with pharmacovigilance on ensuring a holistic approach to monitoring, safety and etc.

Develop and negotiate select budgets, timelines and other expectations in order to establish clear expectations. Accountable for financial oversight of the project/program with the project team leader.

Considered a leader in clinical development and is able to present plans and strategies holistically at scientific congresses, with KOLs, and with regulatory agencies.