Clinical Operations Leader

• Location: Swiftwater, PA

About the Job 

As Clinical Operations Leader within our R&D team, you'll take on a key clinical leadership role that drives the operational success of critical clinical projects from strategy to execution. Ready to get started? 

The Clinical Operations Leader is a pivotal role within our clinical development organization, directing and managing clinical project operational activities to ensure deliverables are completed on time, within budget, and to the highest quality standards. You'll work closely with our Global Clinical Development Strategy Expert and extended clinical teams, serving as the trusted liaison between various platforms within Global Clinical Development and key enabling functions including Global Regulatory Affairs, Pharmacovigilance, Finance, Medical, and Global Immunology. 

This role involves collaborating with multiple levels of personnel across many teams, regions, and external stakeholders such as advisory boards and contract research organizations. You'll be accountable for optimizing and integrating team resources and competencies through effective program and project management leadership. Your expertise will be crucial in developing the best clinical operational strategies for project success, requiring deep understanding of strategic objectives, clinical operations, and strong interpersonal skills. 

As Clinical Operations Leader, you'll ensure effective cross-functional communication at both project and clinical team levels while consolidating strategic communication across the project. You'll champion innovation in clinical trial designs and foster an entrepreneurial mindset, particularly in adopting digital methodologies and tools within the extended clinical team. Risk management and crisis coordination will be key aspects of your role, ensuring reliable performance and productivity of clinical projects through expert leadership and coordination of clinical activities and services. 

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. 

Main Responsibilities

• Lead and coordinate clinical project operational activities, ensuring deliverables are on time, within budget, and to the highest quality standards. 

• Develop and drive the planning of the Clinical Development Plan — including regulatory submissions — and ensure alignment across the extended clinical team and R&D project team. 

• Act as the key liaison between clinical platforms and enabling functions (Regulatory Affairs, Pharmacovigilance, Finance, Medical, Global Immunology) to resolve issues and maintain effective cross-functional communication. 

• Monitor project progress against strategic objectives and key performance indicators, proactively escalating risks and issues to clinical management. 

• Lead risk management and crisis coordination within the clinical project, facilitating issue resolution and implementing action plans. 

• Consolidate and manage the clinical project budget, working with Business Office, Functional Planners, and R&D Finance to ensure accuracy and efficiency. 

• Foster a culture of continuous improvement and innovation, championing digital methodologies, new clinical trial designs, and lessons-learned approaches within the project team. 

About You 

• Experience: 8+ years of solid experience in the pharmaceutical industry with strong clinical operations and project management experience; proven track record of effectively leading multifunctional teams in a global environment. 

• Soft and technical skills: Exceptional project management, strategic leadership, and communication skills (verbal and written); strong business acumen; ability to drive high-performing cross-functional teams; proactive decision-making; innovative problem-solving; conflict resolution and negotiation skills; culturally aware and adaptable. 

• Education: Master's degree in Life Sciences, Medical Sciences, Pharmaceutical Sciences, Health Sciences, or related scientific/medical discipline

• Familiarity with project management software and digital tools. 

Why Choose Us? 

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. 

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. 

• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. 

• Achieve genuine work-life balance in a supportive R&D environment, with outstanding benefits including flexible working options and comprehensive healthcare. 

• Take on a high-impact leadership role at the heart of clinical program strategy, with direct influence on projects that can exceed $100 million in annual budget. 

• Be based in Swiftwater, one of Sanofi's key R&D hubs in USA, and collaborate with world-class teams across multiple regions and functions. 

• Shape the future of clinical operations by championing innovation, digital methodologies, and entrepreneurial thinking within your project team.