Clinical Operations Leader - Vaccines

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 teams, and Global immunology, especially in the context of issues resolution.

• Ensures effective cross-regional communication to allow clinical teams to function efficiently to achieve global plans.

• Ensures top down/bottom-up communication.

• In collaboration with the GCDSE arranges scientific advisory boards, adjudication committees and experts’ committees, set up, follow-up, communication and manages partnership/alliance with experts.

 Leadership:

• Is a R&D project team member for assigned projects. Actively engaged in decision-making process with other stakeholders in GCD, providing input as needed to Head, GCD and Global Heads of clinical platforms

• Provides guidance on best practices and lessons learned for operational execution of clinical trials. Facilitates operational issue resolution. Leads risk management initiatives for the clinical project to minimize negative impacts to team deliverables.

• Coordinates crisis management within clinical project and interface with Clinical platforms and beyond to define and implement action plan.

• In collaboration with team member’s manager, mentors team members to develop enhanced leadership skills such as consensus-building and conflict resolution. Encourages and supports team member empowerment. Is a trusted liaison for clinical and other stakeholders across platforms and functions.

Budget:  

• Ensures appropriate project level capacity/resource planning and management in conjunction with other functions within GCD.

• Consolidates and review budget and resources allocation for his/her clinical project through transversal reviews and interact with Business Office, Functional Planners and R&D Finance to ensure the Clinical budget and planning is accurate.

• Is accountable for tracking and monitoring the project budget with support of Business Office.

Learning/continuous improvement:

• Supports innovation and entrepreneurial mindset such as clinical trial designs, digital methodologies and tools as well as organization within the clinical project.

• Establishes culture of continuous learning and improvement in the clinical project. Identifies process issues requiring resolution at the project level and proposes solutions.

• Identify opportunities for improving organizational processes to continue to drive organizational excellence.

• Ensures that ‘lessons learned’ approach is built into the review and adoption of new approaches and methods.

• Stays abreast of advances in his/her area of expertise.

The COL has Global and Clinical Program and Project level responsibilities. The COL is responsible for the consolidation and understanding of the project budget that they are assigned to. Due to the nature of this role, project assignments are those associated with Clinical program priorities that are of significant impact to the success of the company. Clinical budgets may exceed $100 million annually and need to be managed efficiently. Key elements of the clinical development process, study design and design to cost, impact clinical budgets and successful achievement of clinical program milestones. The COL plays an important role in the corresponding processes and the coordination of clinical project activities. The COL is a key leadership role within the assigned project. It involves working with multiple levels of personnel from many platforms, in multiple regions. It requires an excellent understanding of franchise strategic objectives and clinical operational strategy and activities as well as superior interpersonal skills. Obstacles to overcome include establishing relationships with multiple cross functional team members and being seen as a trusted, reliable liaison in the team.

About you

Education/experience:

• Bachelors degree and a minimum of 6 years’ experience in pharmaceutical industry.

• Very strong project management experience is required.

• A proven track record of effectively leading multifunctional teams is needed.

• Strong project management skills, transversal and strategic leadership capabilities, communication skills and business acumen are required.

• Ability to drive a high performing cross functional team that empowers and motivates individual members and the team.

• Strong interpersonal skills required to effectively collaborate with customers (physicians, scientists, and managers from various disciplines) and interfaces to set and manage expectations.  

• Project Management Skills

• Business acumen

• Excellent organizational, interpersonal and communication skills (verbal & written)

• Customer and quality focused capability to effectively handle large complicated global projects that integrates various disciplines.

• Proactive with ability to drive decision making process

• Innovative problem solving

• People, Change and Influence management skills

• Ability to set and manage expectations

• Self-motivation, results driven, detail-oriented and good organizational skills

• Ability to resolve conflict

• Strong negotiations skills

• Culturally savvy

• Familiarity with project management software

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 Affirmative 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.

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