Director Clinical Modeling

Location

Cambridge, MA | United States

Job description

Responsibilities

About the Company:

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. More than 110,000 people in over 100 countries at Sanofi are dedicated to make a difference on patients’ daily life, wherever they live and enable them to enjoy a healthier life. As a company with a global vision of drug development and a highly-regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) in the R&D organization including drug discovery, chemical manufacturing and control, translational research, clinical development, and document intelligence in regulatory affairs. Details of the organization and the company’s mission and goals can be found on our website (

Overview:

Clinical Modeling and Evidence Integration (CMEI) is part of Data & Data Sciences (DDS) department, a multidisciplinary platform within Sanofi R&D. DDS leverages digital innovations and availability of abundance drug discovery and development data, provides quantitative partnership, digital strategy and support via expertise in artificial intelligence/machine learning, translation disease modeling, clinical modeling and evidence integration and data enabling/governance.

The CMEI group is seeking to hire a clinical modeling and trial simulation scientist to support modeling & simulation (M&S) and quantitative decision making across drug development stages, focusing from proof of concept (POC) to Phase 3, submission and post marketing. Our objectives include quantifying and optimizing project decision via extensive clinical modeling, machine learning, and In-Silico Trials to enable model-based scenario and what-if testing. Our mission includes quantitative gap identification and filling, reducing and replacing clinical trials. By leveraging the ecosystem of digital and methodological advances and internal, external clinical trial data and real-world data, we aim to enhance project probability of success and facilitate compound differentiation.

As a member of the CMEI team, the individual will:        

• Provide modeling and simulation supports to clinical study and project design and planning to assist decision making.  Specific tasks include PK/PD modeling on dose/population selection, clinical modeling and scenario testing, real world data and historical clinical trial data leveraging, differentiation assessment and probability of success assessment, etc.
• Participate in regulatory filings and response to regulatory requests. Specific tasks including developing programs, reports, and presentations to document and communicate results to the team or regulatory agency. 
• Contribute to methodological research and innovative approaches to meet project needs and optimize development efficiency. Specific tasks include integrating real world data usage and AI/ML in clinical development modeling and decision  
• Closely collaborate with project teams across functions and work in various disease areas including immunology, rare disease, oncology and neurology etc.  

Qualifications & Requirements:

• PhD in quantitative sciences including statistics, biostatistics, mathematics or a field with significant modeling and simulation related content
• 8+ years of industry experience preferred, and the level of appointment depends on experiences 
• In depth understanding of statistical and/or pharmacometrics concepts and techniques
• Ability to conduct methodology research and simulation  
• Proficient in R preferred and SAS and python as a plus  
• Excellent communication/interpersonal skills and highly self-motivated
• Ability to successfully conduct multi-tasks, work independently under minimal supervision; pay attention to details and work well in a team environment.

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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