Modeling & Simulations Scientist II - PKPD Programming

Vertex Inc.•Boston, MA

1d•Remote

About The Position

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.

Requirements

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.

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.