About the job

The Context:

CSO (Clinical Sciences and Operations) is a global organization within R&D clinical development. Our mission is to design and conduct clinical trials. We concurrently run over 300 trials (Phases 1 to 4).

Sanofi is facing major disruptions that have pushed the pharmaceutical industry to move forward with an unprecedented speed to adopt innovative approaches and data technologies in clinical operations. Evolution includes transformation from a traditional EDC Centric process to a Patient Driven ecosystems requiring Decentralized Clinical Trials (DCT) data technologies appropriate to handle new ways of collecting and managing data at high velocity and volume. This requires improved and updated data infrastructure, deployment of digital tools, expansion of new data collection methods and data flows. We establish this new Head of Clinical Data Technology position to lead our organization to seize the opportunities offered by recent technological advancement to augment our Clinical Data systems and tools and to update our data flow to secure the delivery of Sanofi portfolio under today’s highly challenging clinical environment.

In this context, key CSO priorities include simplifying the journey of our patients and sites as well as digitalizing our internal activities, to bring new way of operating, new technologies (higher automation, simplification), and enable faster-and-better decisions via real-time data access, visualization, and analytics.

Our Team:

Within CSO, Clinical Data Management is responsible for ensuring the optimum end to end data flow to benefit our patients, sites, and study teams. Our objective is to eliminate unnecessary data transformations and data integrations by ensuring Quality by Design study and platform set-up. Thus streamlining the data continuum and reducing time to database lock. We strive to adopt risk-based approaches to all Clinical Data Management activities (e.g., data review strategies, UAT, etc.).

Main responsibilities:

Position Overview:

The Head of Clinical Data Technology (CDT) reports to the Global Head of Clinical Data Management (CDM) and works closely with all areas of the CSO platform as well as the Digital related functions.

The ideal candidate will need to have a deep understanding of the ongoing changes in clinical data technologies and the transformation required to meet Sanofi ambition of establishing DCT and AI based automations as standard practices in the next 2 to 3 years. He/She needs to have a forward‐looking and yet pragmatic view on how emerging technology innovations are reshaping the discipline of clinical data technology. He/She needs to have a good understanding of the increasing complexity of healthcare systems, clinical practices, and regulations as well as understanding analytics and AI. He/she works cross-functionally including but not limited with Clinical Operations teams, Monitoring, Biostatistics team and Digital.

The Head of CDT needs to bring vision, passion, leadership, and communication skills to lead strategic changes in our organization.

Key Accountabilities:

This position will lead the transformation/modernization of data technologies in Trial Operations (TO). He/She will also assume the management and operational oversight of Clinical Database Design (DBD), Clinical Data Management Programming (DMP) and Data Integration (DI). The Head of CDT is responsible for effective data technology processes to be deployed across all clinical studies and support the delivery of quality data.

In addition to the strategic data technology leadership responsibilities, the day-to-day missions for this role include but not limited to leading Clinical Data Technology teams to:

• Harness a working environment which encourages teamwork, energy, and creativity.
• Rally his/her team behind the department strategy and maintain a high level of engagement despite the significant departure from traditional CDM roles and responsibilities.
• As an active Extended TO LT member, ensure the effective deployment of data technologies for clinical studies under TO scope while minimizing disruption to ongoing activities.
• Assume Business System Ownership for our clinical data systems and tools.
• Steer clinical data technologies strategy in our programs to streamline data flows enabling prompt data acquisition, review and database locks.
• Support clinical study teams with technical knowledge skills on metadata, audit trail, data collection, data flow, story telling data analytics and data integration
• Ensure the data collection and advanced data review tools and processes are in place to run data management activities efficiently
• Drive the automation of data related activities within TO scope
• Support CDM Merger and Acquisition activities.

About you

Education and professional Experience

• Master’s degree in relevant scientific and/or computer sciences field and a minimum of 10 years’ experience in clinical research within pharmaceutical industry.
• Successful experience in managing complex studies/programs.
• 5 years of Global Leadership and people management experience
• Ideally, experience with eSources, Decentralized Clinical and AI
• Experience in Clinical project management, process improvement and/or Digital implementation in data flow strategy, digital innovations, or RBM implementation
• Strong business Acumen skills: Ability to promptly and efficiently deal with complex and cross-functional "business situation" (risks and opportunities) in a manner that is very likely leading to a positive outcome.
• Work experience in complex clinical IT environments and related processes such as Software Development Life Cycle (SDLC)
• Knowledge of clinical operations and clinical data technologies including audit trails, metadata and advanced analytics (e.g., Storytelling and/or predictive data analytics)

Soft skills

• Strong interpersonal, negotiation and communication skills with a customer focus mentality.
• Excellent communication skills
• Ability to decide when needed and take responsibility (accept accountability for results)

Technical skills

• Up to date on regulations regarding clinical data collection and clinical data standards such as: GCP (Good Clinical Practice), Code of Federal Regulation Part 11, data privacy, and data specific regulations like GDPR (General Data Protection Regulation)

• Up to date knowledge on clinical data management systems and data flow including complex data streams (e.g; sensors, imaging, biomarker, eSource)
• Strong Understanding of industry standards & terminologies (e.g., CDISC SDTM, MedDRA)
• Strong understanding of the following advanced drug development concepts is preferred:

Languages

• Fluency in English, both oral and written

Pursue Progress. Discover Extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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.