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 6 years experience or Master's Degree and 10 years experience in the application of Pharmacometric and other Modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies.

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Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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]