Executive Director, Modeling & Simulations

General Summary:

The Executive Director, Modeling & Simulations (M&S) manages strategic, scientific and operational aspects of M&S within the Early Clinical Development Department at Vertex. The incumbent is responsible for the implementation of modeling and simulation strategy at Vertex; including but not limited to traditional PK/PD, population PK, exposure-response, model-based meta-analysis, clinical trial design and simulation, mathematical disease models, mechanistic modeling and analyses of multidimensional data This role will have final approval on providing direction and guidance for M&S plans across programs.

Key Duties and Responsibilities:

• Leading and developing the Modeling & Simulation team
• Champion the use of modeling and simulation to impact decision making in clinical and exploratory development
• Manage a group of senior leaders comprised of Senior Directors and Director level employees
• Provide expert input for internal review of all documents internal and external related to modeling and simulation or M&S derived outputs
• Represent programs in external partnerships and advisory boards
• Oversee and contribute to regulatory and safety documents
• Represent modeling and simulation during face-to-face regulatory interactions
• Provide management and career development to associate program leads
• Assist in recruitment and hiring for the M&S group.

Knowledge and Skills:

• Demonstrated ability to lead teams and manage people
• Experience designing clinical pharmacology and pharmacometrics components of filing packages and associated clinical studies
• Regulatory agency interactions including written responses and IND packages
• End of Phase 2 and NDA/MAA regulatory experience
• Support of drug development programs in all Phases including life-cycle management
• Strong experience leading cross-functional teams
• Academic or clinical post doctoral training with significant publication history
• Superior communication skills
• Proactive problem solver and demonstrated ability to work in a matrix environment

Education and Experience:

• Master's or PhD in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling
• Typically requires the following: PhD with 20 years or Master's Degree with 25 years’ experience in the application of pharmacometric and other modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies
• Strong management experience

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