Associate Director, Pharmacometrics, Clinical Pharmacology

Travere • San Diego, CA

1d • Hybrid

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
• 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
• Driven, intelligent, passionate about making a difference for patients with rare diseases
• Self-motivated and can independently manage responsibilities
• Ability to perform face to face work with colleagues and/or onsite in San Diego
• Ability to travel (<10%)

Nice To Haves

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

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

Benefits

• premium health, financial, work-life and well-being offerings for eligible employees and dependents
• wellness and employee support programs
• life insurance
• disability
• retirement plans with employer match
• generous paid time off
• competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees