Director, Modeling and Simulation

Flagship Pioneering•Cambridge, MA

About The Position

Flagship Pioneering is seeking a highly motivated Director to provide leadership and hands-on support for pharmacokinetic/pharmacodynamic (PK/PD) and quantitative systems pharmacology (QSP) modeling across its diverse drug discovery portfolio. The role partners with teams across the Flagship ecosystem, from newly founded ventures to later-stage portfolio companies, applying mechanistic modeling to translate scientific concepts into potential therapies. The Director will support internal and external due diligence, guide platform companies in accelerating programs from Lead ID to DC, and apply innovative modeling approaches to early feasibility concepts. As programs advance through Lead OP and pre-IND, the role integrates modeling workstreams into cross-functional development strategy and collaborates with clinical teams to support the design and interpretation of emerging clinical data. The Director will also manage a small team of modeling scientists and CROs, with responsibility for scientific oversight, budgets, and timelines for externalized model development.

Requirements

PhD in pharmacology, engineering sciences, (bio-)physics, or applied mathematics.
At least 5 years of experience in QSP and/or PK/PD modeling; 8 or more years, including direct experience managing scientists and/or CRO relationships, is expected for the Director level.
Advanced experience in QSP modeling workflows and a deep understanding of mechanistic, physiologically based modeling principles.
Biological subject matter expertise in at least one disease area.
Programming skills in a language such as R, Python, or Matlab.
Hands-on modeling experience using Simbiology, NONMEM, Monolix, Pumas, or similar software.
Experience supporting drug discovery programs, including due diligence and early feasibility assessments.
Excellent oral and written communication skills and the ability to work in a multidisciplinary team with colleagues and collaborators from diverse backgrounds.

Nice To Haves

Familiarity with population PK/PD methods, such as nonlinear mixed-effects modeling and Bayesian methods.
Experience with AI-supported and/or agentic modeling workflows.
Track record of representing scientific work externally, such as through publications, conference presentations, or scientific advisory interactions.

Responsibilities

Work with cross-functional development teams and platform companies to identify modeling needs, appropriate model complexity, and required data.
Use modeling to de-risk program questions related to safety and efficacy, inform TCP and/or TPP, guide preclinical in vitro and in vivo studies, test MoA-related hypotheses, conduct competitor analysis, and support target prioritization.
Support clinical translation of preclinical data, including first-in-human dose predictions.
Support regulatory interactions, such as FDA meetings and IND-enabling packages, through model-informed drug development approaches.
Develop QSP and PK/PD models, internally or with CROs, across multiple modalities and therapeutic areas.
Guide early-stage Flagship companies to help accelerate timelines from Lead ID to DC.
Use AI-supported modeling workflows for end-to-end support, including model scoping, development, calibration, and analysis, to accelerate due diligence and early feasibility decision-making.
Ensure modeling infrastructure, including software, methods, and external consulting support, is efficient and meets required standards.
Manage a small team of modeling scientists and CROs, providing scientific oversight and accountability for budgets and timelines for externalized model development.