Executive Director, Modeling & Simulations

Job Description

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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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]