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Department:

106750 Clinical Development

Location:

San Diego, 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 individual will be responsible for the design, leadership, and implementation of Modeling and Simulation strategies across Travere clinical programs. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You will set the strategy for addressing pharmacometric issues and directly influences drug development decisions. The successful candidate will have good quantitative pharmacology skills, scientific reasoning, exploratory graphical analysis skills and report writing skills.

Responsibilities:

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This position will be responsible for developing and executing modeling and simulation strategies from the early through late-stage clinical development and serve as the SME in cross-functional development program teams

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This position will play a key role in delivering strategic and well-timed modeling input at key decision points along the development path

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The ideal candidate will set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions

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Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies

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Use state of the art modeling and simulation approaches to interpret PK/PD data and accountable and responsible for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and exposure-response analysis

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Guide empirical modeling/QSP approaches to understand relationship between PK, biomarkers and disease outcomes

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Education/Experience Requirements:

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PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) required

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3-6 years experience in NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation in academia and/or industry

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Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas

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Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification, study design among others

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Hands-on experience with at least NONMEM and R is strongly preferred.

Additional Skills/Experience/Requi rements:

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The ideal candidate will embody Travere's core values: Courage, Community Spirit,... For full info follow application link.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer