Modeling & Simulations Scientist II - PKPD Programming

Job Description

General Summary:

The Modeling & Simulations Scientist II-(PKPD Programming) is a primarily hands-on programming leader responsible for delivering high-quality PK/PD, PopPK, and exposure-response analysis datasets, outputs, and regulatory submission deliverables, while advancing process standardization, automation, and quality across Phase 1-3 studies. This role also provides team and operational management through resource planning, mentoring, workload coordination, and oversight of programming activities to ensure timely, compliant, and efficient delivery. By combining technical expertise with people leadership, the position supports Clinical and Quantitative Pharmacology objectives and contributes to the successful execution of the development portfolio.

Key Duties and Responsibilities:

• Lead hands-on PK/PD programming deliverables by creating, validating, and delivering analysis-ready datasets, outputs, and supporting files for Population PK, PK/PD, and exposure-response analyses, ensuring high-quality and timely support for clinical pharmacology objectives.
• Drive programming quality, consistency, and process standardization across studies by establishing, refining, and implementing repeatable workflows, specifications, QC practices, and programming standards to improve efficiency, reduce risk, and support inspection readiness.
• Provide technical oversight and quality control of analysis datasets and data manipulation by reviewing programming methods, validating derived datasets, and ensuring outputs used by analysts are accurate, traceable, and fit for purpose.
• Develop and maintain automated programming solutions for Phase 1-3 studies to streamline dataset generation, reporting, and submission preparation, thereby optimizing timelines and increasing operational scalability.
• Support regulatory and clinical study reporting deliverables by managing submission-ready packages, including datasets, scripts, model files, and related documentation, and contributing to TFL outputs and clinical pharmacology sections of CSRs or other study documents as needed.
• Provide day-to-day leadership, mentoring, and technical guidance to PK/PD programmers by coaching team members, supporting skill development, and promoting sound programming practices and decision-making to strengthen overall team capability.
• Manage programming resources, priorities, and workload planning in collaboration with Clinical and Quantitative Pharmacology stakeholders to ensure appropriate support across the portfolio, alignment to timelines, and proactive identification of resource gaps or competing demands.
• Monitor delivery performance and resolve operational issues by tracking progress, reporting status and metrics, addressing escalations, and identifying root causes and corrective actions to maintain reliable and effective programming support.
• Ensure team readiness, compliance, and operational support by confirming programmers have appropriate system access, training, tools, and procedural guidance needed to perform work in accordance with quality standards, regulatory expectations, and company processes.

Knowledge and Skills:

• Strong knowledge of PK/PD, Population PK, and exposure-response programming, including development and QC of analysis-ready datasets and outputs to support clinical pharmacology analyses.
• Advanced proficiency in R programming and strong understanding of clinical trial data structures, derivations, and traceability.
• Solid understanding of quality control, validation practices, and regulatory submission requirements for datasets, scripts, model files, and related documentation.
• Demonstrated ability to standardize processes and implement automation to improve quality, consistency, and efficiency across studies.
• Effective project, priority, and stakeholder management skills, with the ability to coordinate multiple deliverables and resolve operational issues in a fast-paced environment.
• Proven people leadership, mentoring, and communication skills to guide programmers, support development, and ensure high-quality delivery aligned with business needs.

Education and Experience:

• B.s, M.s, or PhD with preference in Pharmaceutical sciences, Pharmacometrics, mathematics, computer science, statistics, or other quantitative discipline.
• Typically requires the following: PhD and 0 years' experience or Master's Degree and 4 years experience or Bachelor's degree and 6 years of experience in the application of programming or 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 Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. 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-Remote

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 ApplicationAssistance@vrtx.com