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Associate Director, Modeling & Simulation, Pkdm US

Expired Job

Sanofi Bridgewater , NJ 08807

Posted 3 months ago

Support clinical phase development project teams as a modeling and simulation (M&S) expert for the Pharmacokinetics, Dynamics, and Metabolism (PKDM) department:

  • Conduct translational and population PK, PK/PD analysis, exposure-response analysis, clinical trial simulation, PBPK analysis, and other model-based analyses

  • Formulate and execute PK/PD and M&S strategies for specific projects to inform dose selection and go/no-go decisions

  • Develop and review protocols, analysis plans, and study reports for M&S aspects

  • Prepare regulatory documents and representing M&S at regulatory meetings when needed

Knowledge and Skills
1.Develop the following scientific skills:

  • Perform translational and population PK and PK/PD analysis, exposure-response analysis, clinical trial simulation, and other model-based analyses independently under minimal supervision

  • Understand the strategic elements of drug development

  • Apply a logical and structured approach to file management

  • Develop departmental procedures (SOP's, Protocols, Safety Procedures)

  • Train/mentor others
    2.Demonstrate the following scientific competencies:

  • Serve as M&S representative for PKDM on development projects

  • Recommend a course of action to solve M&S issues

  • Act as a resource to address technical and theoretical issues in the M&S area

  • Be able to operate in a multicultural environment and participate in international teams

  • Prepare and issue stand-alone M&S reports with minimal review

  • Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA

  • Can represent Sanofi to regulatory agencies

  • Prepare abstracts, posters and manuscripts for external presentation and/or publication

  • Identify skill-sets necessary to advance career development
    3.Ensure that all assigned project activities are performed in compliance with current departmental SOP's, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.

  • Demonstrate excellent leadership

  • Possess excellent interpersonal communications skills commensurate with working in a multicultural organization

  • Independently accountable for meeting project timelines

Formal education and experience required:

  • Technical expertise in several of the following areas: translational and population PK and PK/PD modeling, exposure-response modeling, Clinical trial simulation, PK/PD modeling and simulation, PBPK modeling, drug-disease modeling

  • Proficiency with the use of one or more of the following software packages: NONMEM, R, SAS, Monolix, Matlab, Phoenix

  • Ph.D. with or without post-doctoral experience in pharmaceutical sciences, pharmacometrics, mathematics, statistics, computational biology, chemical/biomedical engineering, system pharmacology, computer science, or closely related discipline plus at least 6 years of industry experience with a record of increasing responsibility and independence

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.



At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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Associate Director, Modeling & Simulation, Pkdm US

Expired Job