The Opportunity:

We are seeking a QSP modeling & simulation scientist to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) organization. This position will be responsible for developing, validating, and executing modeling projects with a focus on mechanistic PBPK-QSP mathematical models for small molecule programs to increase mechanistic understanding of compound PK behavior and drug distribution, pharmacological effects on RAS targets, support clinical translation, and drive future discovery and development efforts.  As a Quantitative Systems Pharmacologist, you will:

• Develop, validate, execute, and refine quantitative systems pharmacology (QSP) models, minimal physiologically based pharmacokinetic (PBPK) models, semi-mechanistic PK/PD models, and tumor growth models to support development and discovery phase projects including next-generation inhibitor design and assessment of combination potential.

• Propose and perform in silico simulations to answer complex mechanistic questions, create data visualizations to effectively communicate modeling results to a wide-ranging audience, and devise strategies to improve model outputs.

• Survey the related literature to understand key physiological and biological processes, abstract the basic mechanistic elements, identify the relevant data, and summarize assumptions to be incorporated into existing or new PBPK-QSP models.

• Propose new mechanistic in vitro and in vivo experiments to test model assumptions and structure. Provide in silico support for preclinical translation including clinical efficacious doses/exposure projection, potential combination dosing regimens with other cancer therapeutics.

• Work collaboratively with other functions to build internal infrastructure supporting data transfer and quality control.

• Document contributions, including assumptions, mathematical models, data analyses, and data visualizations, to be shared with other scientists or used for archival purposes.

Required Skills, Experience and Education:

• A Ph.D. in a quantitative discipline (systems pharmacology, computational biology, engineering, mathematics, physics, etc.) and 0-2 years of industry experience is desired.

• Strong understanding of the principles and limitations of mathematical modeling, pharmacokinetic models, pharmacodynamic models, and quantitative systems pharmacology/biology models.

• Proficiency in mathematical and computational methods including ordinary differential equations (ODEs), nonlinear systems, statistics, optimization, and parameter inference.

• Proven record developing, calibrating, and validating dynamical system models in pharmacological and biological systems.

• Demonstrable hands-on experience with programming languages used in scientific computing, such as MATLAB, Python, Julia, and R.

• Capable of working proactively and independently to deliver high–quality modeling results in a timely manner.

• Able to effectively communicate modeling assumptions, limitations, and simulation results to non-specialist and specialist audiences.

• A critical thinker and team player who can work cross-functionally with others.

Preferred Skills:

• Experience with diverse dynamical system methods like ODE-based, PDE-based, nonlinear mixed effects, agent-based, Markov, Boolean, etc.

• Experience with integrating large data sets into QSP.

• Experience with agentic coding workflows such as Copilot, Cursor, Codex, and Claude Code.

• Experience with data-driven methods such as ML-based predictive regression models and physics-informed neural network models.

• Experience with modeling software such as SimBiology, NONMEM, Pheonix WinNonlin, Monolix, Simcyp designer, etc. 

  #LI-Hybrid #LI-CT1

The Opportunity:

We are seeking a passionate and experienced Clinical Pharmacologist with strong early development background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization. 

As a member of the Early Development Clinical Pharmacology group, you will:

• Provide strategic insight and technical leadership within the Clinical Pharmacology function.

• Author technical reports and/or regulatory documents for major milestones of clinical development, specifically IND, EOP1 & EOP2 Briefing Documents. Participate in regulatory interactions and responses to regulatory questions.

• Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to guide recommended phase 2 dose/schedule (RP2Ds) selection for pivotal studies.

• Work with the Discovery organization to support assets in the IND-enabling stage, including collaboration with DMPK and Toxicology groups in assessment of human start dose and assessment of the need for human DDI studies.

• Work with the Clinical Development team in designing FIH study.

• Design and report Clin Pharm studies such as hADME, Food-Effect and DDI studies.

• Engage and work with CROs on clinical pharmacology activities.

• Represent the Clinical Pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.

Required Skills, Experience and Education:

• A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 5+ years of relevant experience in Clinical Pharmacology.

• Prior experience with small molecules oncology drug development.

• Familiar with FDA’s Project Optimus guidance. 

• Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology.

• Hands-on experience with WinNonlin and Clin Pharm study designs.

• Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance is required.

• Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.

• A critical thinker and passionate team player and quick learner with high energy who thrives in a dynamic and fast-paced environment.

• Prior management experience.

Preferred Skills:

• Prior experience interacting with FDA on dose optimization.

• Hand-on experience with PBPK models. #LI-Hybrid #LI-CT1