Director, Modeling and Simulation

Flagship Pioneering, Inc.•Cambridge, MA

3d•$172,000 - $236,500

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 drug discovery portfolio. The role partners with internal and external teams, from newly founded ventures to later-stage portfolio companies, to apply mechanistic modeling and translate scientific ideas into potential therapies. The Director supports internal and external due diligence, guides platform companies in accelerating programs from Lead ID to DC, and applies innovative modeling approaches to early feasibility questions. As programs advance through Lead OP and pre-IND, the role integrates modeling into cross-functional development strategy and collaborates with clinical teams to support the design and interpretation of emerging clinical data. The position also manages a small team of modeling scientists and CROs, with scientific oversight and accountability for external model-development budgets and timelines.

Requirements

PhD in pharmacology, engineering sciences, (bio-)physics, or applied mathematics.
At least 5 years of experience in QSP and/or PK/PD modeling; Director-level candidates are expected to have 8+ years, including direct experience managing scientists and/or CRO relationships.
Advanced experience in QSP modeling workflows, deep understanding of mechanistic and physiologically based modeling principles, and biological subject-matter expertise in at least one disease area.
Programming skills, such as R, Python, or Matlab.
Hands-on modeling experience using Simbiology, NONMEM, Monolix, Pumas, or similar software packages.
Experience supporting drug-discovery programs, including due diligence and early-feasibility assessments.
Excellent oral and written communication skills and 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 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 mechanism-of-action hypotheses; conduct competitor analysis; support clinical translation of preclinical data, including first-in-human dose predictions; and inform target prioritization.
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, for 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 modeling support, including model scoping, development, calibration, and analysis, to accelerate due diligence and early-feasibility decision-making.
Ensure supporting 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 external model-development budgets and timelines.
Integrate modeling workstreams into cross-functional development strategy as programs advance through Lead OP and pre-IND.
Collaborate with clinical teams to support the design and interpretation of emerging clinical data.