Associate Director, Modeling - Boston, United States - Vertex

Description

Job Description

General Summary:

The Associate Director, Modeling & Simulation will combine strong pharmacometric skills with deep biological understanding to independently determine, plan, and execute M&S analyses in close collaboration with cross-functional colleagues within the R&D organization. This incumbent determines, plans, and executes technically challenging analyses by using state of the art Modeling & Simulation methodologies to strongly contribute to critical decision making. The incumbent will lead M&S projects to evaluate study design, dose selection, probability of success estimation, portfolio strategy, pediatric extrapolation, etc. The incumbent will represent M&S with cross-functional drug development teams and clearly communicate M&S results. Finally, the incumbent will have general management duties, including possible oversight of managers and professionals, and/or management of a team(s).

Key Duties and Responsibilities:

• Independently develops M&S analysis plans in alignment with an asset strategy, determines relevant outcomes, executes, and interprets multiple modeling analyses
• Perform mechanism-based PKPD and population PK and PK/PD analyses, clinical trial simulations, translational modeling (preclinical – clinical) and other model-based analyses and in collaboration with other scientists on a regular basis
• With significant independence, perform dataset construction, evaluation and interpretation of results, and pre- and post-processing activities including informative graphics creation
• Represents M&S on cross-functional drug development teams
• Serves as the M&S lead on pharmacometric deliverables for a study, including population PK, PKPD, exposure-response, model-based meta-analysis, trial simulation, etc.
• Participates in preparation of regulatory responses

Knowledge and Skills:

• Possess specialized, in-depth experience in M&S and excellent research record in the area of M&S, such as design and analysis of nonlinear mixed models, dynamic models, mechanistic models, adaptive designs with respect to model fitting, estimation, optimization, in particular differential equation dynamic modeling.
• Deep understanding of biology, pharmacokinetic and quantitative pharmacology (PKPD) principles.
• Advanced skills with the use of NONMEM PsN, R, and similar tools
• Excellent collaborative, leadership, 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 6 years experience or Master's Degree and 10 years of 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 156,000.00 – 234,000.00 USD annually