Associate Director, Pharmacometrics, Clinical Pharmacology

Travere Therapeutics•San Diego, CA

1d•$150,000 - $195,000•Remote

About The Position

The individual will be responsible for the design, leadership, and implementation of Modeling & 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.

Requirements

PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) required
4+ years experience of relevant industry experience required including experience in NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation
Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
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
Hands-on experience with at least NONMEM and R is strongly preferred.
Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a small, fast-moving and entrepreneurial environment.
Ability to manage multiple, complex tasks with competing timelines.
Strong interpersonal, verbal, and written communication skills.
Self-motivated and can independently manage responsibilities.
Ability to travel (<10%).

Nice To Haves

The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
Driven, intelligent, passionate about making a difference for patients with rare diseases.

Responsibilities

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
Delivering strategic and well-timed modeling input at key decision points along the development path
Set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions
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
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
Guide empirical modeling/QSP approaches to understand relationship between PK, biomarkers and disease outcomes