Modeling & Simulations Director

The Modeling & Simulations Associate Director will develop and execute M&S strategies and activities in cross-functional drug development project teams, collaborating closely with colleagues in Clinical Pharmacology, Biostatistics, Research, and other R&D groups. This role determines, plans, and executes technically challenging analyses using state-of-the-art Modeling & Simulation methodologies to support critical decision-making.

Responsibilities

• Serve as Modeling & Simulations (M&S) lead in one or more cross-functional drug development teams, developing and executing M&S plans and analyses fully integrated with overall development plans.
• Use state-of-the-art Modeling & Simulation methodologies to contribute to critical decision-making, such as study design, dose selection, and probability of success estimation.
• Independently perform mechanism-based PKPD and population PK/PKPD analyses, clinical trial simulations, and other model-based analyses.
• Support the continuous improvement of M&S capabilities by contributing to training activities and evaluating/incorporating new M&S tools.

Requirements

• 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, and disease progression modeling.
• Proficiency in tools such as NonMem, PsN, R, Phoenix, and similar software.
• Demonstrated strong leadership, collaboration, and influencing skills.
• Excellent verbal and written communication skills.
• In-depth experience working in clinical development teams and integrating PK/PD modeling or modeling of complex biological systems.

Qualifications

• Master’s or PhD in Pharmaceutical Sciences, Pharmacometrics, Mathematics, Statistics, or another quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling.
• Typically requires a PhD with 10 years or a Master’s Degree with 15 years of experience in applying pharmacometric and other modeling methodologies in drug research & development (industry, academia, or regulatory agencies).

Pay

Pay range: $194,400 – $291,600. This role is eligible for an annual bonus and annual equity awards. Some roles may also qualify for overtime pay in accordance with federal and state requirements. Actual base salary will be based on skills, competencies, experience, and other job-related factors permitted by law.

Benefits

• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in summer and winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan.

Schedule

This is a hybrid-eligible role, allowing you to work remotely up to two days per week or choose to work on-site five days per week with ad hoc flexibility. Flexibility status is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.