Sanofi Group Global Head of Clinical Data Strategy and Integration in United States

The Global Head of Clinical Data Strategy and Integration reports to the Vice President of Trial Operations and works closely with all areas of the Clinical Sciences and Operations (CSO) platform and the clinical IT function, in the US, France, China and abroad.

The ideal candidate will need to bring leadership skills, vision, communication skills, passion and understanding of the complex healthcare systems and treatment areas (common practice and guidelines) as well as understanding big data analytics to work cross-functionally with other groups such as the Clinical Operations team, Commercial, etc. to accomplish our vision. The person in this position will drive the Sanofi Clinical Data strategy of 2020 and beyond, defining how we integrate data from various sources, driving the digitalization and digitization of clinical data collection, management and reporting. A strong vision and proven track record of implementation of strategic changes is a must and good insight in Clinical Information Governance for today and the future a strong asset.

This position manages various global teams including, data project management, database design, clinical data experts, risk based monitoring and clinical information governance teams. Within the Trial Operations department, he/she will lead the Group dedicated to Clinical Data Strategy & Integration . Responsible for high quality data management across all clinical studies, including technical, operational and process components of Database Design, Data Integration, Data management Programming, Centralized Data monitoring, Data Project Management and Data operations.

The Global Head will lead and drive the vision and strategy of the data management of the future.

  • Simplify protocols

  • Industrialize risk based monitoring approach leveraging data from numerous sources.

  • Enabling identification of potential issues faster

  • Pull data from various sources such as:

  • CRF

  • eClinical Outcome Assessments and ePatient Reported Outcomes

  • eHealth Records

  • wearables

  • Develop process for automation of Data Management

The day-to-day missions for this role are to:

  • Steer clinical data strategy in our programs

  • Enable lead CTOMs and the study teams to ensure timely collection and cleaning of clinical data over the course of the study

  • Manage resources dedicated to the implementation, management and analysis of clinical databases, from the first to the last step

  • Define clinical risk-based and patient-centered strategies for data.

  • Contribute to protocol design and actively collaborate in data modeling/simulation to this end

  • Support clinical study teams with specialized and technical knowledge /skills on data management and data integration

  • Support international teams in accordance with the strategy defined by the Clinical Trial Team

  • Ensure the tools and processes are in place to run integrated data management activities

  • Drive strategic innovation with regards to clinical data (including but not limited to):

  • Direct eHR to eDC

  • Digital data collection: Wearables, eCOA

  • Real time data integration for different sources

  • Next industry innovations on clinical data

  • Link data collection to a broader Big Data strategy for the department

  • Drive discussions on strategic data collection for product profiles and filing strategy, in a timely manner and with respect to legal and financial regulations

  • Harmonize and Optimize Trial Operations processes related to data collection and management.

Basic Qualifications:

MSc or PhD in clinical operations, biostatistics, clinical data management, clinical development or equivalent and 10 years of experience in medical/pharmaceutical industry

·

Preferred Qualifications:

1 0 years in clinical research and 4 years of clinical data project management in clinical operations is preferred

Up to date on regulations regarding clinical data collection and on clinical data standards such as: GCP (Good Clinical Practice), GDMP (Good Data Management Practices), data privacy, and new regulations like GDPR (General Data Protection Regulation)

Work experience in complex clinical IT environments and related processes

Proven ability to simplify complex processes, and to develop guidelines and tools for large groups

5 years of Leadership and people management experience, with at least 2 years managing and supporting global teams

Proven experience in clinical data management leadership roles

Thorough knowledge of clinical operations and clinical data processing

Up to date knowledge on clinical data management systems and data flow

Successful collaboration with teams in China, India, Europe (France) and US.

Successful experience working in close collaboration with functions like medical operations, biostatistics, DM/stats programming, clinical quality, clinical ITS

Excellent communication skills, both oral and written in English

Managed Projects to an end in complex environments

Client and solution focused mind-set

Experience in Clinical project management, process improvement and/or ITS implementation in CDM strategy, digital innovations, or RBM implementation

Knowledge and understanding of regulatory perspectives on clinical data integration

Proper knowledge in « New Drug Application (NDA)/ Market Authorization Application

(MAA) », including previous experience with regulatory submission of product files and FDA discussions.

#LI-SA

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life