Job Description

General Summary:

The Associate Director, Modeling & Simulation will combine strong pharmacometric skills with deep biological understanding toindependently 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

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journeywhile providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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Company Information