Job Description
Sanofi is a leading bio-pharmaceutical company committed to advancing healthcare through groundbreaking research and development. The Clinical Innovation team at Sanofi is responsible for identifying, accelerating, and scaling innovations that can serve to improve operations and/or outcomes for patients, sites, and sponsors of clinical trials. The Clinical Innovation team includes our digital biomarker strategy and operations team which focuses on establishing and executing digital biomarker programs that generate health-related data through digital health technologies (DHTs), provide valuable insights into patients' conditions, and aid in improving the clinical trial experience. This is a director level role that will focus on utilizing DHTs and related data to create digital endpoints in clinical trials, ensuring accurate evaluation of treatment outcomes, and advancing Sanofi's scientific understanding of disease. As we continue to drive excellence and innovation in our clinical trials, we are seeking an exceptional professional to join us as a Clinical Strategy Lead for Digital Endpoints. Job Overview The Clinical Strategy lead for Digital Endpoints drives and augments Sanofi’s success in R&D by defining and executing innovative digital biomarker strategies across our R&D portfolio. The role is responsible for end-to-end integration with clinical studies, and the role identifies, creates, validates, and operationalizes both fit-for-purpose and novel digital endpoints in Sanofi’s clinical studies. Collaborating across teams, the role ensures seamless integration of therapeutic area needs with cutting-edge technologies, delivering impactful solutions to patients and enhancing our clinical programs. Additionally, the role will contribute to identifying, testing, and adopting new technologies that show promise for clinical digital measurement and growing Sanofi’s digital biomarker expertise and thought leadership. Key Responsibilities Digital Endpoint Strategy Development and Execution: Identify opportunities for digital endpoint/outcomes strategies in collaboration with clinical teams to integrate novel and fit for purpose digital measures into clinical studies. The role will work closely with the therapeutic area teams to understand the strategic needs across Sanofi’s portfolio, and the role will be responsible for establishing and understanding the DHTs available to create value for patients, programs, and operations. The role will also communicate the respective value and potential of the available DHTs to development and partner teams and throughout all stages of the lifecycle of a drug. Lead cross-functional teams in creating integrated plans to develop, validate, and deploy digital endpoints. The role will be responsible for recommending digital endpoints and driving the cross-functional teams to select or design the respective DHT both to address meaningful aspects of health and to add value to Sanofi’s development portfolio. Operationalize digital endpoint strategy programs and serve as the primary point of contact, organize and manage multi-workstream efforts to meet strategic goals. The role will be responsible for creating and executing the integrated validation and testing plans to support strategic study timelines and goals. Additionally, the role will create and implement KPIs, and communication strategies to inform leadership of milestones, and results. The role will work closely with the Digital Biomarker Operational Leads and to ensure the operational needs for each study are defined, communicated, and executed. Integrate essential inputs such as health authority feedback, legal, intellectual property, data use, and privacy considerations into the Digital Endpoint strategy to ensure feasibility. Revise and communicate strategic and operational plans when appropriate while ensuring the patients’ needs are at the core of the deliverables. External Representation Represent Sanofi Clinical Innovation internally and externally to the biopharma and digital biomarker communities. Communicate the potential and value of digital biomarkers, educate about the processes and considerations when incorporating digital endpoints into programs and studies, and recommend opportunities for innovation. Drive The Clinical Innovation Team Forward Contribute to the growth of the digital biomarker organization, identify unmet needs within the organization with respect to process and strategy, propose and execute solutions. Collaborate to deliver agile and effective change management. As an expert, remain up to date on the internal digital endpoints portfolio, on current and emerging technologies, industry mile