Clinical Operations Leader - Vaccine

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.

• The Clinical Operations Leader (COL) is a key clinical leadership role within the assigned project.

• The COL directs and manages clinical project operational activities in collaboration with the Global Clinical Development Strategy Expert (GCDSE) and the extended clinical team and is accountable for ensuring clinical project deliverables are on time and within budget.

• The COL is the trusted and reliable chief liaison between the various platforms within Global Clinical Development (GCD) and acts as well as an interface with other enabling functions such as Global Regulatory Affairs, Pharmacovigilance, Finance, Medical, Global Immunology, especially in the context of issues resolution. Therefore, it involves working with multiples levels of personnel from many teams, in multiple regions, and with external stakeholders (e.g., advisory boards, CROs).

• The COL is accountable for ensuring the deliverables of the clinical project via effective program, project management and leadership skills in a manner that will optimize integrate and utilize the team’s resources and competencies.

• The COL will support the clinical project strategy by providing expertise to develop the best clinical operational strategy for the success of the project. It requires an excellent understanding of project strategic objectives and clinical operational activities as well as appropriate interpersonal skills.

• The COL ensures an effective cross functional communication, at project and clinical team levels, and consolidates strategic communication at project level.

• The COL supports innovation in clinical trial designs, entrepreneurial mindset such as the use of digital methodologies and tools, as well as in the organization within the extended clinical team.

• The COL is a key role in risk management initiatives and coordinates crisis management within the project.

• The chief accountability is to ensure reliable performance and productivity of Clinical project by leading and coordinating clinical project activities and services. Accountable for project deliverables within GCD, including the timelines, quality, and budget.

Key Accountabilities:

• Provides operational input into the clinical project strategy by providing expertise to develop the best clinical operational and scientific strategy for the successful conduct of the project

• Knowledgeable about and understands overall project and franchise strategy. In collaboration with the GCDSE, provides support for clinical project governance.

•  Develops, manages, and drives the planning of the clinical project performed as part of the Clinical Development Plan, ensures its feasibility of execution and its execution. This also includes planning and driving the execution of the clinical sections of the required regulatory submissions (i.e. CTD, eBLA and others as appropriate).

• Ensures the Clinical Development Plans and project plannings as well as their updates are communicated throughout the Extended Clinical Team and the R&D Project Team and ensures alignment with R&D global project strategy.

• Accountable for Clinical project performance to ensure it meets expectation with respect to timelines, quality, and budget.

• Contributes to ensure harmonization of activities (operational strategy) in between studies within a program as well as transversally and across clinical projects.

• Monitors projects’ progress and performance against strategic objectives and key performance indicators.

• Ensures proactive, timely reporting on progress of program management components of clinical trials, openly escalate issues that require input from and discussion with members of Clinical Management.

• May be responsible for more than one clinical project, depending on project scope and individual experience.

Communication/Interfaces:

• Consolidates strategic communication at project level and maintains cross functional communication

• Use clinical project analytics to communicate on issues/risks/alerts.

• Acts as an interface between the Extended Clinical Team and other enabling functions such as Global Regulatory Affairs, Pharmacovigilance, Quality, Global Medical, Transformation and performance