Quantitative Systems Pharmacology (QSP) Lead – Rare Disease Portfolio

Responsibilities

• Design and implement an end-to-end QSP operating model, including standardized deliverables, timelines, quality gates, documentation, and decision packages that ensure modeling outputs are reproducible, reviewable, and actionable in governance forums.
• Identify and prioritize high-impact QSP use cases aligned with key program decision points, translating modeling needs into focused work plans that maximize development impact.
• Develop and apply mechanistic or semi-mechanistic disease and drug models (e.g., ODE-based frameworks), ensuring strong documentation, version control, and reproducibility.
• Develop and apply mechanistic and semi-mechanistic QSP models, including virtual patient simulations and in silico trials, to inform dose selection, trial design, and risk assessment, ensuring strong documentation, reproducibility, and scientific rigor.
• Generate QSP models, virtual patients, and in-silico trial simulations where appropriate and high-value, particularly in early capability build-out or critical decision moments.
• Balance hands-on modeling with strategic oversight, determining when to execute internally versus leverage external partners based on impact, timing, and complexity.
• Identify, evaluate, and manage external QSP or disease-modeling vendors, including scope definition, deliverables, timelines, and quality oversight.
• Retain full scientific and technical ownership of all externally generated outputs, ensuring alignment with internal assumptions, standards, and decision needs.
• Use virtual patient approaches and in-silico trials to derisk development, explore dose and regimen options, and assess disease heterogeneity and scenario sensitivity.
• Produce clear, decision-grade analysis packages explaining assumptions, limitations, sensitivity analyses, and implications for development and trial design.
• Drive alignment on priorities, expectations, and delivery timelines in a matrix environment.
• Partner closely with Clinical Development, Clinical Pharmacology/PMx, Biostatistics, Translational, Regulatory, and other functions to align on QSP priorities, expectations, and delivery timelines in a matrix environment.
• Define a phased roadmap for scaling QSP capabilities over time, including recommendations for future hiring and optimal use of external partners.

Qualifications

• PhD in Biomedical Engineering, Systems Biology/Pharmacology, Applied Mathematics, Computational Biology, or a related quantitative discipline preferred.
• 12+ years of experience in pharmaceutical/biotechnology development with a minimum of 3 years of QSP modeling.
• Demonstrated experience delivering QSP or mechanistic modeling to inform drug development decisions, including dose selection, trial design, and/or regulatory strategy.
• Prominent ability to operate in a matrix environment, integrating quantitative insights into cross-functional decision-making.
• Strong expertise in QSP modeling frameworks (e.g., MATLAB, R, Julia, or Open Systems Pharmacology Suite), with strong emphasis on model development, validation, and reproducibility.
• Rare disease experience preferred.