Director, Modeling & Simulations

Nimbus Therapeutics has an outstanding opportunity for a Director, Modeling & Simulations to join our team.  Reporting to the Head of DMPK, this role will lead modeling & simulations efforts within the organization and collaborate with key stakeholders across Development & Discovery functions to plan, develop and integrate relevant analyses across nonclinical stages in the Drug Development pipeline. 

In this role, you will: 

• Develop and execute modeling & simulation plans and analyses across various stages of Nimbus’ Drug Development pipeline
• Serve as the internal modeling & simulations subject matter expert and contribute to overall strategy, study design, dose selection, probability of success estimation, etc. in support of early pharmacology and PKPD studies
• Conduct mechanism based PBPK, PKPD, Population PK, and other model-based analyses
• Improve efficiency and effectiveness of Nimbus’ M&S capability, utilizing and incorporating various M&S tools as appropriate
• Represent DMPK as the subject matter expert to project teams
• Integrate ADME and PK information to guide project team efforts in drug discovery
• Design and execute preclinical studies to understand the PK of drug candidates that support both drug discovery and preclinical and clinical development
• Responsible for the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external collaborators
• Build and develop quantitative tools to interrogate the PK/PD relationship and project from preclinical to clinical stage using modeling and simulation
• Collaborate extensively with clinical and nonclinical pharmacology teams, and integrate modeling and simulation into decision making

These qualifications will help this role be successful: 

• Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutical Science or other relevant field with 7+ years of experience in the biopharmaceutical industry
• Strong understanding of DMPK, PK/PD modeling and human dose predictions to enable the design of preclinical and clinical studies.
• Hands-on experience with relevant modeling software and programming languages including MATLAB, R, Python, WinNonLin/Phoenix, NONMEM, etc.
• Prior experience with regulatory submission (e.g., IND, BLA and/or NDA) is a plus.
• Excellent verbal and written communication and organizational skills required with experience working on cross functional teams.
• Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment. 

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