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The Clinical Study Units (CSUs) are a strategic function driving end-to-end clinical development to deliver innovative therapies to patients. CSUs shape the evolving healthcare environment, build partnerships with investigators, patients, and stakeholders, execute clinical programs aligned with Sanofi’s medical, digital, and product strategies, support market readiness, and enhance company reputation.
Key Responsibilities
Lead the Country CSU to deliver clinical studies with quality, efficiency, and compliance with ICH-GCP, regulatory requirements, and Sanofi standards.
Drive operational excellence through continuous improvement, lessons learned, digital innovation, and quality-by-design approaches.
Optimize study portfolio execution through resource planning, site strategy, recruitment forecasting, risk management, budget oversight, and performance monitoring.
Build and maintain strong networks with investigators, hospitals, and KOLs to support current and future clinical programs.
Ensure country readiness through effective governance, quality oversight, and inspection preparedness.
Provide strategic input to global and regional teams on study planning, protocol optimization, feasibility, and clinical development strategies.
Develop and execute the long-term CSU strategy aligned with R&D, Global Medical Affairs, and Clinical Study Operations priorities.
Leverage clinical intelligence, Real-World Data, analytics, and digital capabilities to improve study planning, productivity, and innovation.
Monitor healthcare trends, regulatory changes, and competitive landscape to strengthen local clinical capabilities.
Partner with Medical Affairs and cross-functional teams (Regulatory, Finance, Procurement, Legal, Compliance, HR, Pharmacovigilance) to support clinical development objectives.
Drive KOL and investigator engagement, study communication, and CSU visibility within the affiliate.
Represent Sanofi in relevant industry forums and strengthen relationships with clinical research partners.
Lead country clinical operations, including resource planning, site selection, feasibility assessment, study milestones, and operational performance.
Ensure timely communication of study progress, risks, and insights across local, regional, and global stakeholders.
Oversee local requirements including documentation, regulatory submissions, contracts, translations, and vendor activities.
Promote a strong culture of quality, compliance, and Health, Safety & Environment (HSE).
Lead, coach, and develop a high-performing CSU team through effective recruitment, capability building, performance management, and succession planning.
Manage CSU budgets, resource allocation, forecasting, and cost optimization in partnership with regional leadership.
Foster accountability, collaboration, and continuous learning across the organization.
Provide strategic oversight of FSPs and local vendors to ensure quality, compliance, and effective clinical study delivery.
Monitor vendor performance, risks, capacity, and service delivery against agreed timelines, budgets, and KPIs.
Partner with Procurement and regional teams on vendor selection, implementation, and governance.
Advanced degree in Life Sciences, Medicine, Pharmacy, or related scientific discipline (MSc, MD, PharmD, PhD).
10+ years of clinical research experience, including 3+ years of people management experience.
Strong knowledge of clinical development, ICH-GCP, and global/local clinical trial regulations.
Proven ability to lead teams and influence cross-functional stakeholders.
Strong clinical development and Medical Affairs expertise.
Strategic thinking and business acumen with ability to align clinical operations with organizational priorities.
Excellent leadership, change management, stakeholder engagement, and coaching skills.
Strong risk management, problem-solving, and decision-making capabilities.
Data-driven mindset with experience using analytics and digital tools.
Strong project and vendor management capabilities.
Commitment to ethics, quality, and patient-centricity.
Excellent written and verbal communication skills in English and local language.
Experience in Regulatory Affairs, Market Access, Medical Affairs, or external vendor management.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
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