Executive Director, Modeling & Simulations

Vertex Pharmaceuticals•Boston, MA

1d•Hybrid

About The Position

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.

Requirements

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

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.