Modeling & Simulations Senior Scientist

Job Description

General Summary :

The Modeling & Simulations Senior Scientist at Vertex will lead Modeling & Simulation analyses from planning through reporting and align these analyses with the strategy determined by the modeling program lead. Types of analyses can include m odeling and simulation to support evaluation of study design, dose selection, probability of success estimation, portfolio strategy, pediatric extrapolation etc. It is expected that this role will work in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Research and other colleagues within the R&D organization The M&S Senior Scientist contributes to evaluation of study design, dose selection, probability of success estimation, portfolio strategy, pediatric extrapolation etc.

Key Duties and Responsibilities :

Development and execution of Modeling & Simulation plans and analyses fully integrated with the overall development plans

By using state of the art Modeling & Simulation methodologies, strongly contribute to critical decision making like study design, dose selection, probability of success estimation, etc.

Contribute to the continuous improvement in efficiency and effectiveness of our M&S capability by supporting training activities, evaluating and incorporating new M&S tools as appropriate

Perform mechanism based PKPD and population PK and PK / PD analyses, clinical trial simulations, translational modeling (preclinical – clinical) and other model-based analyses in collaboration with other scientists on a regular basis

Contribute M&S expertise to multiple projects, including as the lead representative for specific analyses and evaluate and interpret analysis results

Contribute to the continuous improvement in efficiency and effectiveness of our M&S capability by supporting training activities, evaluating and incorporating new M&S tools as appropriate

Organizes and participates in departmental functions and represents the department in company-wide, non-scientific initiatives

Integrate modeling into decision making by clearly communicating key results

Knowledge and Skills :

Strong experience working in clinical development teams and integrating the use of PK / PD modeling and / or modeling of complex biological system

A deep understanding of biology, pharmacokinetic and quantitative pharmacology (PKPD) principles

In-depth hands-on skills in population PK and PKPD modeling, mechanistic PKPD modeling, Clinical trial simulations, Disease progression modeling, etc.

Advanced skills in the use of NonMem, PsN, R, Phoenix, and similar tools

Excellent, verbal and written communication skills

Education and Experience :

Master's or PhD, with preference in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling

Typically requires the following : PhD and 3 years experience or Master's Degree and 6 years experience in the application of Pharmacometric and other Modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies.

Pay Range 142,400 00 – 213,600 00 USD annually