Manager, Modeling & Simulation, PKDM US
Bridgewater, New Jersey
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare.
The Modeling and Simulation (M&S) group in the Pharmacokinetics, Dynamics, and Metabolism (PKDM) department at Sanofi US provides clinical pharmacokinetic/pharmacodynamic analysis and M&S support to enable critical decision making and to accelerate Sanofi ongoing programs in translational medicine, early clinical development, late stage clinical development, and post-marketing across different therapeutic areas including immunology, oncology, hematology, and rare diseases.
The individual in this position will support clinical phase project teams as a M&S expert for the PKDM department in Development at Sanofi
- Conduct population PK and PK/PD analysis, exposure-response analysis, clinical trial simulation, and/or other model-based analysis using different M&S software to characterize the kinetics of drug disposition and to assess the dynamics of drug effect
- Develop and apply state-of-the-art quantitative methodologies (mathematical, physiological or statistical M&S) to support clinical phase projects and execute M&S strategies 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 when needed
Knowledge and Skills
1. Develop the following scientific skills:
- Under minimal supervision, perform population PK modeling, mechanistic PK/PD modeling, exposure-response analysis, clinical trial simulation, and/or other model-based analyses such as disease modeling, survival analysis, time to event analysis, and machine learning
- Apply a logical and structured approach to file management
- Develop departmental procedures (SOP’s, Protocols, Safety Procedures)
- May train/mentor others
2. Demonstrate the following scientific competencies:
- Serve as M&S representative for clinical development projects
- May recommend a course of action to solve M&S issues
- Can 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
- Participate in the preparation of protocols and/or analysis plans
- 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 presentation and/or publication
- Present at external scientific meetings as appropriate
- 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.
- Possess excellent interpersonal communications skills commensurate with working in a multicultural organization
- Demonstrate a proficiency at scheduling multiple activities
- Independently accountable for meeting project timelines
- Ph.D. with or without post-doctoral experience in pharmacometrics, pharmaceutical sciences, clinical pharmacology, mathematics, statistics, computational biology, chemical/biomedical engineering, system pharmacology, computer science or closely related discipline plus at least 4 years of relevant experience with a record of independence
- Technical expertise in several of the following areas: population PK and PK/PD modeling and simulation, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling
- Strong background in different M&S software such as NONMEM, R, Monolix, Phoenix NLME, ADPAT, Matlab, PKsim, SimCYP, SAS, Python, and/or C/C++
- Excellent oral and written communication skills and strong problem-solving skills
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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