Global Head of Clinical Development - Vaccines

Job title: Global Head of Clinical Development - Vaccines

• Location: Swiftwater, PA

About the Job

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Build and maintains detailed knowledge of overall R&D strategy for Sanofi Vaccines and able to articulate the impact / effect this strategy has on Clinical R&D and how Clinical R&D contributes to the broader strategic goals and objectives of Sanofi Vaccines, portfolio, and project evolution.

• Accountable for leading Global Clinical Science in ensuring effective, timely and robust design and management of Sanofi Vaccines’ clinical programs and studies (in support of obtaining regulatory approval), while always ensuring safety, efficacy and appropriate benefit/risk to patients / subjects. Incumbent is responsible for all Clinical sciences activities for vaccine projects globally. 

• Coordinates with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Global Clinical Immunology and Global Medical Affairs. Directly manages clinical Sciences research staff involved in Phase I - IV trials and the preparation of associated documents for submission to the appropriate regulatory agencies. Serves as primary contact to clinical sites, the FDA, and the medical community for medical/clinical issues. 

• Responsible for ensuring consistent application of standards within Clinical Development globally and work with the global platform heads of Clinical Operations and Medical. Identifies and champions innovative approaches to clinical vaccines development.

• In addition, this position represents the Company within the medical & scientific research community through involvement in international scientific meetings and through professional publications.

• Lead for all platforms within Clinical Operations (Clinical Operations Lead, Global Clinical Study Management, Biostatistics, Data Management, Vaccines Clinical Documentation, Transformation & Performance Office).

• Optimize availability of resources to meet project requirements (contributes to the development of global functional budget and creates and implements functional budgets to meet both project and functional milestones). Provide guidance for problem resolution, working with platform leaders, functional team members and clinical team leaders

Key Accountabilities:

Clinical Sciences

• Provides relevant, functional (Clinical Sciences) input to support the development of the strategy for Clinical R&D; provides specific medical / scientific information towards this end.

• Identifies key stakeholders / interfaces outside of Clinical R&D that impact the ability to deliver on the Clinical R&D strategy.

• Ensures clinical capacity of medical systems to participate in clinical trials in accordance with quality and compliance standards.

• Provides input and expertise to jointly develop a consistent Clinical R&D policy and approach to implementing and monitoring quality and process improvement initiatives.

Strategic Planning Accountabilities

• Builds and maintains detailed knowledge of overall R&D and Franchise strategy for Sanofi-Vaccines and Sanofi- and can articulate the impact / effect this strategy has on Clinical R&D and how Clinical R&D contributes to the broader strategic goals and objectives of Sanofi Vaccines.

• Identifies opportunities, needs, and risks for Clinical Development in driving innovation and delivering new vaccines to the market

• Integrates specific factors that impact the ability to achieve and maximize submissions (e.g., Health Economics, Outcomes Research, regulatory landscape, quality, and compliance standards).

• Sets goals and objectives for Clinical Sciences a) globally b) at respective regional level.

• Systematically and regularly evaluates local, regional, and global initiatives-determines the relative importance and value of each against corporate strategic objectives. Assesses need for medical and clinical infrastructure in markets.

• Applies decision criteria to prioritize regional focus and efforts.

• Builds medical and clinical infrastructure in markets to support execution of clinical R & D programs – engages