Clinical Operations Study Country Lead (COSCL)

Job Title: Clinical Operations Study Country Lead (COSCL)

Location: US Remote

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.

We are seeking a highly motivated and experienced Clinical Operations Study Country Lead to support US clinical trial operations. The COSCL will be a strategic leader within the Clinical Study Unit (CSU), accountable for the planning, execution, and oversight of clinical trials from country allocation through study closure and archiving. This role ensures compliance with Sanofi SOPs, ICH/GCP, and local regulatory requirements, while leveraging AI-driven solutions to optimize processes. As the primary interface between the CSU and the global study team (COSL), the COSCL represents the country in global meetings, escalates risks, and owns national-level decisions to ensure successful study delivery. The role involves close collaboration with internal and external stakeholders to enhance operational efficiency and accelerate trial execution. The ideal candidate will possess a deep understanding of current digital technologies, AI applications, and direct experience implementing innovative solutions to deliver transformative approaches for our patients.

Job Purpose:

Clinical Operations Study Country Lead:

• This person will lead the strategic and operational execution of clinical trials at the country level

• Ensure alignment with global study objectives, Sanofi SOPs and local regulatory requirements while driving innovation through AI and digital transformation

• Accountable for study delivery, end to end planning, compliance and performance

• Key role in advancing Sanofi’s digital clinical development strategy

• Contribute to Sanofi’s commitment to accelerate the development of new drugs for all patients through our clinical trials

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:

Clinical Operations Study Country Lead:

• Lead strategic planning, execution and oversight of US clinical trials, ensuring alignment with global strategy, timelines, budgets and local regulatory guidelines

• Lead digital transformation by identifying, and implementing AI-driven solutions to enhance trial efficiency, site performance and patient engagement, and promote ethical AI use, data privacy and governance

• Represent the US in global study meetings, escalate risks, make global-level decisions to support study success

• Oversee study start-up activities, including feasibility, selection and recruitment strategies by leveraging digital tools and AI analytics to ensure site readiness and performance

• Foster strong communication with internal teams, vendors and external partners, and lead stakeholder communication, sharing best practices for AI use and learnings

• Manage local study budgets, monitor financial performance and ensure data integrity, patient safety, audit readiness and quality oversight

• Leverage data analytics to inform decisions, identify digital opportunities and develop business cases that drive operational value

About You:

Basic Qualifications

• US: Bachelor's Degree within health, science, or engineering role with 3 years experience.

Preferred Qualifications:

• Knowledge of clinical trial life cycle
• Experience in CRO environment
• Understanding of startup activities
• Exposure to FDA requirements and guidelines

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.