Clinical Operation Study Country Lead

Job Title : Clinical Operation Study Country Lead

Location : US / Remote

About the Job

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.

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.

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

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

Qualifications :

Bachelor's Degree within health, science, or engineering role

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

Proven expertise in assessing and implementing digital technologies in clinical development

Strong knowledge of GCP, ICH guidelines and US regulatory requirements

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

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

Preferred certifications include CPMAI, AIPM, or Google AI

Excellent written and verbal communication skills with strong stakeholder management

Proficient in project, risk and change management methodologies

Fluent in English

Willingness to Travel

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.