Role Summary
Associate Director Quantitative Data Modeling — Morristown, NJ. Lead model-based analyses across population PK/PKPD, disease progression modeling, and advanced methodologies (data analytics, machine learning, mechanistic modeling) to support Sanofi’s internal pipeline with minimal supervision.
Responsibilities
- Ability to formulate drug development questions and develop modeling and simulation strategies for optimizing model-informed drug development from first-in-human dosing through life cycle management.
- 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.
Qualifications
- Required: Ph.D. in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics, data science, computational biology, chemical/biomedical engineering, system pharmacology, computer science or closely related discipline with at least 5 years of industrial experience and increasing responsibility.
- Required: Technical expertise in translational and population PK modeling, PK/PD modeling, exposure–response modeling, clinical trial simulation, drug–disease modeling, PBPK modeling, and advanced methodologies such as data analytics, machine learning and mechanistic modeling.
- Required: Strong background in M&S software (e.g., NONMEM, R, Monolix, Phoenix NLME, PUMAS, Matlab, PKSim, SimCYP, SAS, Python, C/C++, Julia).
- Required: Excellent oral and written communication skills and strong problem-solving abilities.
- Required: Demonstrated ability to integrate and analyze internal and external data to support decision making and generate scientific insights; knowledge of industry best practices and regulatory standards.
Skills
- Strong quantitative skills including mathematics, statistics, data science, AI/ML, etc.
- Experience with advanced population modeling approaches (e.g., PPK, PKPD) and complex data analytics, AI/ML, and mechanistic modeling.
- Ability to serve as an M&S representative for clinical development projects and act as a subject matter expert on technical issues.
- Ability to operate in a multicultural, international team and prepare stand-alone M&S reports with minimal review.
- Experience preparing regulatory submissions and scientific communications (abstracts, posters, manuscripts).
Education
- Ph.D. in a relevant field (see Qualifications) or closely related discipline.