Clinical Operations Study Country Lead

Job Title: Clinical Operations Study Country Lead (COSCL)

• Location: Morristown, NJ

About the job

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.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

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:

• Bachelor's Degree within health, science, or engineering field

• Minimum 3 years of experience in clinical research, including project management and clinical trial oversight

• Strong knowledge of GCP, ICH guidelines and US regulatory requirements

• Familiarity with machine learning in healthcare, and understanding of AI ethics and governance

• Excellent written and verbal communication skills with strong stakeholder management

• Proficient in project, risk and change management methodologies

• Fluent in English

• Willingness to Travel

Preferred Qualifications:

• Proven expertise in assessing and implementing digital technologies in clinical development

• Advanced digital literacy with hands-on experience in AI-powered tools and data analytics

• Preferred certifications include CPMAI, AIPM, or Google AI

• Proficient in standard digital tools and platforms for study management, communication, data collection, organizing, and reporting

• Able to guide and motivate study teams in day-to-day operations, with capability to make decisions and delegate tasks effectively

• Developing skills in strategic vision and long-term team development

• Competent in identifying, assessing, and monitoring study-related risks

• Proficient in pl