Digital Biomarker Innovation Clinical Lead

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress.

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 (DBM) 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. The DBM Innovation Lab is the newest capability within the team, established to accelerate adoption of DBMs as trial endpoints, and maximize probability of success for implementation.

In this role as a DBM Innovation Clinical Lead - Signal-Seeking Studies, you will design and lead exploratory studies, early data generation and device evaluation programs to foster high-confidence, high-value digital biomarker (DBM) implementation in Sanofi trials. This position leverages your extensive clinical expertise, scientific acumen, and research experience to advance digital endpoints that accelerate delivery of novel therapies to patients.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Own end-to-end development and delivery of signal-seeking studies, applying rigorous scientific methodology to generate early evidence supporting DBM programs and strategy

• Collaborate with the broader DBM team and stakeholders to develop research hypotheses grounded in clinical relevance, then design high-quality experiments to inform patient-centric decisions

• Deliver scientific leadership and subject matter expertise in digital biomarker development, combining your clinical knowledge with technical fluency to drive innovation

• Establish the DBM Innovation Lab (“iLab”) as high-performing function, leveraging your scientific credibility to accelerate adoption of validated digital endpoints in clinical trials

Key Activities

• Engage with clinical and trial operations leaders to translate complex clinical needs into actionable digital biomarker testing strategies

• Develop project plans and value/KPI frameworks that demonstrate clinical utility and scientific validity

• Collaborate with data scientists and biostatisticians to design methodologically sound approaches for matching research questions with appropriate study settings, ensuring insights have clinical relevance or translatability

• Direct development of study protocols with scientific rigor that meet strategic needs and right-sized regulatory standards

• Evaluate digital health technologies with critical scientific assessment of their measurement properties and clinical applicability

• Lead study execution with attention to scientific integrity, implementing improvements based on quantitative and qualitative feedback

• Present research findings at conferences, regulatory meetings, and to senior leadership

• Contribute to strategic DBM iLab roadmap development using evidence-based approaches to balance clinical needs, technical feasibility, and strategic value

• Support execution of user preference studies, applying your understanding of patient-reported outcomes and clinical meaningfulness

• Maintain cutting-edge knowledge of the digital biomarker landscape through scientific literature review, continuing education, and attendance at professional meetings

• Develop deep expertise in digital health data architecture and analytics, aligning R&D data science use cases with key datasets

• Lead search and evaluation for emerging digital health technologies, applying clinical judgment to identify those with greatest potential impact

• Develop processes, operating practices and infrastructure to accelerate and sustain DBM iLab efforts. Support/create training and educational webinars to help establish a knowledge base of digital health technologies and digital endpoints within Sanofi

• Build external thought leadership in digital endpoints, representing Sanofi in scientific consortia, regulatory discussions, and academic collaborations

About You

Required Qualifications

• Advanced degree in health sciences with 8-10 years of experience in life sciences, healthcare, medical devices, pharma or a related field

• Strong knowledge about the regulatory requirements around DHT in clinical development applications, and critical success factors and obstacles impacting clinical trials and outcomes

• Big picture orientation and understanding the interplay of drug development, digital health, data science, regulations and the changing pharmaceutical and healthcare environments

• Experience designing and executing scientific research studies

• Proven track record of success of delivering research outcomes which drive decisions

• Proven ability to collaborate and influence across functions in a highly matrixed organization

• Strong ability to communicate (verbal, written, slides) clearly across technical and non-technical teams

• Self-motivated, organized, can-do attitude, collaborative, open-minded, excellent time-management

• High standards for user experience, not limited to evaluation of DBMs in the participant and trial context, but also for internal studies and collaborative workshops

Preferred Qualifications

• Familiarity with clinical trial operations, including protocol development, country/site planning and / or digital transformation in R&D

• Product management experience

• Agile or continuous improvement experience

• MBA or consulting experience

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.