Modeling & Simulations Director

Job Description

General Summary:

The Modeling & Simulations Associate Director will be responsible for developing and executing M&S strategies and activities in cross functional drug development project teams in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Research and other colleagues within the R&D organization. This role determines, plans, and executes technically challenging analyses by using state of the art Modeling & Simulation methodologies to strongly contribute to critical decision making.

Key Duties and Responsibilities:

• As Modeling & Simulations (M&S) lead in one or more cross functional drug development teams, responsibilities include the development and execution of Modeling & Simulation plans and analyses fully integrated with the overall development plans
• By using state of the art Modeling & Simulation methodologies strongly contribute to critical decision making like study design, dose selection, probability of success estimation etc.
• Independently perform mechanism based PKPD and population PK and PKPD-analyses, Clinical trial simulations and other model based analyses on a regular basis
• Contribute to the continuous improvement in efficiency and effectiveness of our M&S capability by supporting training activities, evaluating and incorporating new M&S tools as appropriate.

Knowledge and Skills:

• A specialized understanding of biology, pharmacokinetic and quantitative pharmacology (PKPD) principles.
• Excellent hands-on skills in population PK and PKPD modeling, mechanistic PKPD modeling, Clinical trial simulations, Disease progression modeling, etc.
• Excellent skills in the use of NonMem, PsN, R, Phoenix, and similar tools
• Demonstrated strong leadership-, collaborative and influencing skills
• Excellent, verbal and written communication skills
• In-depth experience working in clinical development teams and integrating the use of PK/PD modeling and/or modeling of complex biological system

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 10 years or Master's Degree and 15 years 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:

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. 

#LI-Hybrid
 

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]