Clinical Operation Study Country Lead

Sanofi; Brasil; Teletrabalho; BRL 659.000 - 953.000; Tempo integral

Resumo da oferta

A leading biopharma company is seeking a Clinical Operations Study Country Lead to oversee clinical trials. Responsibilities include strategic planning, ensuring compliance, and driving innovation through AI. The ideal candidate will have a Bachelor's in health, science, or engineering, combined with at least 3 years of clinical research experience. This position offers a competitive salary range of $122,250.00 - $176,583.33 and is open to US residents.

Serviços

Health and wellbeing benefits

14 weeks’ parental leave

Promotional and growth opportunities

Qualificações

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

Responsabilidades

• Lead the strategic and operational execution of clinical trials at the country level.
• Ensure alignment with global study objectives and local regulatory requirements.
• Oversee study start-up activities and manage local study budgets.

Conhecimentos

Clinical research expertise

Project management

Digital technology assessment

Knowledge of GCP/ICH

AI literacy

Stakeholder management

English fluency

Formação académica

Bachelor's Degree in health, science, or engineering

Ferramentas

AI-powered tools

Digital analytics tools

Descrição da oferta de emprego

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.

Key Responsibilities

• 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

Main Responsibilities

• 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, elevate 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 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.

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 Affinnaitive 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.

Eligibility

US and Puerto Rico Residents Only

North America Applicants Only

Salary

The salary range for this position is:
$122,250.00 - $176,583.33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.