General Summary:
The Executive Director, Modeling & Simulations (M&S) manages strategic, scientific and operational aspects of M&S within the Early Clinical Development Department. Implements Vertexโs modeling and simulation strategy (e.g., 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). Provides final approval on direction and guidance for M&S plans across programs.
Key Duties and Responsibilities:
- Lead and develop the Modeling & Simulation team
- Champion M&S to impact clinical and exploratory development decision-making
- Manage a group of senior leaders (Senior Directors and Directors)
- Provide expert input for internal review of documents related to M&S or M&S-derived outputs
- Represent programs in external partnerships and advisory boards
- Oversee and contribute to regulatory and safety documents
- Represent M&S 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:
- Lead teams and manage people
- Design clinical pharmacology and pharmacometrics components of filing packages and associated studies
- Regulatory agency interactions (written responses and IND packages)
- End of Phase 2 and NDA/MAA regulatory experience
- Support drug development programs in all phases (including life-cycle management)
- Lead cross-functional teams
- Academic/clinical postdoctoral training with significant publication history
- Superior communication skills
- Proactive problem solver; works in a matrix environment
Education and Experience:
- Masterโs or PhD in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with emphasis on Pharmacometrics and PK/PD modeling
- Typically: PhD with 20 years or Masterโs with 25 years applying pharmacometric and other modeling methodologies in industry/academia/regulatory agencies
- Strong management experience