Study Director Community Lead

Oversee the execution and delivery of a portfolio of GCO supported clinical studies for Novartis, of diverse complexities and priorities, in accordance with the Clinical Development Plan (CDP) and Operational Execution Plan (OEP). The assigned portfolio is a set a clinical trials of similar types defining a Study Leadership community.

Provide developmental support and guidance to Study Leaders within the community in navigating stakeholders and operational aspects of clinical trials in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and specific country regulations. This covers all operational aspects of a clinical trial.

This is a hybrid position based in Basel, Switzerland offices.

About the Role

Major accountabilities but not limited to:

• Leader of a Study Leadership community. This includes people management responsibility within the Study Leadership organization
• Promotes operational excellence and knowledge sharing across studies.
• Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.
• Oversees people allocation (resource management) within assigned community. Oversees the execution and delivery of a portfolio of GCO supported clinical studies for Novartis of diverse complexities and priorities within the assigned community.
• Leads independently the Clinical Trial Team (CTT) together with the CSL in collaboration with the Clinical Operations Program Head (COPH), delivery of multiple complex global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and a team of team’s model.
• Acts as the CTT product co-owner with duties and responsibilities for delivery of the operational strategy per established ways of working.
• Guides planning and decision making at the study level and delivers assigned clinical study/studies per the Operational Execution Plan (OEP) and clinical study protocol.
• Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies in order to achieve long-term business impact.

Education and Experience:

• Bachelor’s degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred.
• Fluent in English - oral and written
• 8 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV studies of medium to highly complexity
• 5 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of medium to highly complexity and of high priority for Novartis (e.g., planning, executing, reporting, and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations
• 5 years recent people management in a complex matrix environment. Experience in managing people globally strongly preferred
• Management of virtual teams. Proven ability and strong experience leading teams and building capabilities
• Experience in developing effective working relationships with internal and external stakeholders
• Excellent communicator and presenter (oral and written); ability to communicate at all levels

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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.