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The Associate Director will play a key role in advancing Sanofi’s internal pipeline across multiple therapeutic areas by conducting a broad spectrum of model-based analyses, spanning population PK and PK/PD modeling, disease progression modeling, and advanced methodologies such as data analytics, machine learning, and mechanistic modeling. The incumbent will contribute to data-driven decision making and the application of innovative modeling strategies with minimal supervision.
Job Responsibility:
Formulate drug development questions and develop modeling and simulation strategies for optimizing model-informed drug development in all stages of development
Conduct with minimal supervision model-based analyses such as population pharmacokinetics (PPK), PK/PD, exposure response, model-based meta-analysis, clinical trial simulations and disease progression modeling to drive internal pipeline forward
Conduct innovative quantitative methodologies such as data analytics, machine learning and mechanistic modeling as needed
Serve as M&S representative for clinical development projects
Act as a subject matter expert addressing 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
Prepare abstracts, posters and manuscripts for external presentation and/or publication
Present at external scientific meetings as appropriate
Identify skill-sets necessary to advance career development
Ensure that all assigned project activities are performed in compliance with current departmental SOP’s, guidelines, industry best practices and regulatory guidelines
Requirements:
Ph.D. in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics, data science, computational biology, chemical/biomedical engineering, system pharmacology, computer science or closely related discipline
At least 5 years of industrial experience with a record of increasing responsibility and independence
Strong quantitative skills including mathematics, statistics, data science, AI/ML
Deep and extensive experience with advanced population modeling approaches (e.g. PPK, PKPD) and complex methodologies such data analytic, AI/ML and mechanistic modeling
Proficiency in conducting model-based analyses using standard pharmacometrics software (e.g., NONMEM, R, Monolix, etc.)
Proficiency in integrating and analyzing internal and external data to support decision making
Strong written and verbal communication skills, interdisciplinary collaboration, problem scoping and planning
Good knowledge of industry best practices, global regulatory, processes, standards of drug development
Technical expertise in several areas ranging from classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling, to advanced complex methodologies such as data analytics, machine learning and mechanistic modeling
Strong background in different M&S software such as NONMEM, R, Monolix, Phoenix NLME, PUMAS, Matlab, PKsim, SimCYP, SAS, Python, C/C++, Julia
Excellent oral and written communication skills and strong problem-solving skills