Head of Feasibility

Job Title: Head of Feasibility

Location: Swiftwater, PA

About the Job

The Head of Feasibility (HF) is responsible for developing winning country, site, patient, and data strategies to ensure the platform’s operational success with adherence to study timelines. In this role you will provide expert guidance on country and site selection strategies, regulatory considerations and start-up timelines, as well as patient access considerations, using operational experience, clinical trial knowledge, real-world data (RWD) and predictive analytics, thus ensuring efficient, accelerated and successful operational delivery. You will oversee the design of each therapeutically customized site identification and patient strategy with the start-up team, collaborates with Project Management Leads, Clinical Trial Management, as well as drug development experts, to ensure that the overarching strategy is operationally realized within the agreed upon timelines and budgets. You will apply an objective and data-driven approach to significantly influence the functional strategy, designed to give the competitive edge.

The Head of Feasibility will exhibit an in-depth understanding of emerging use of real-world evidence (RWE) and predictive analytics; demonstrate an ability to discover, evaluate and/or recommend innovative data-driven approaches; and a willingness to explore ground-breaking technologies in RWE, AI or other spaces, ensuring is the global leader in feasibility.

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:

Vaccine Strategy and Coordination

As a member of Global Clinical Study Management Team:

• Knowledgeable about overall R&D and Franchise strategy for Sanofi Vaccines; understands the implications of the strategy for Clinical Programs.

• Provides relevant, knowledge and insights to support the development of the Global Platform strategy; provides specific information and insights.

• Actively engages in decision-making process with other Platform Management Team members, providing input as needed to Global Platform Head. As appropriate, also works with CPMT members and colleagues across Clinical R&D, to support cross-functional problem solving and decision-making.

• Ensures proactive, timely reporting on progress of operational components of clinical trials and communicates operational opportunities and risks to the Global Platform; openly raises issues that require input from and discussion with other members of the global platforms and addresses questions from colleagues.

• Stays abreast of the needs of partners and key stakeholders and works with other CPMT members to create integrated plans for collaborating effectively with partners and stakeholders and ensuring optimal delivery of clinical studies.

• Provides regular, up to date, consistent and accurate reports on operational components of ICH-GCP compliance, quality standards and regulatory considerations for his /her platform.

Leadership / Management

• Leads and manages a Study Startup team within the CSM platform.

• Manage team members of a global and multicultural platform; 8+ direct reports, 5 indirect reports, plus outsourced resources.

• Focuses on developing skills and capabilities that support strategic goals and objectives of the function, including alignment with the GCD organization.

• Attracts, motivates and retains qualified staff to ensure the attainment of GSM platform objectives.

• Manage team members of a global and multicultural platform; 8+ direct reports, 5 indirect reports, plus outsourced resources.

• Negotiates for her/his assigned programs, resources (FTEs and funding) to meet the clinical requirements of the clinical programs/projects in order to ensure the timely and efficient meeting of the program or project clinical milestones.