Join to apply for the Senior Study Leader role at Novartis.

Summary

The Senior Study Leader oversees all operational aspects of clinical trials end-to-end, including planning, execution, data collection, and interpretation. Responsible for budget and people allocation within assigned study/studies. Promotes operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learn, and adjust quickly to changing conditions and business needs. Accountable for resolution of study management operational issues and impediments within assigned study/studies.

This is a hybrid position with 12 days per month from the office in White City, London.

Key Responsibilities

• Leads the clinical trial team delivery of multiple medium to complex global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset and an agile team-of-teams model.
• Acts as the CTT product owner with duties and responsibilities per the agile 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 to achieve long-term business impact.
• Collaborates with regulatory writing and clinical development to promote operational excellence in the development of global clinical study protocols and study-related documents.
• Creates effective CTT dynamics and achieves performance, prioritization, and communication in close collaboration with CTT sub-team leaders.
• Proactive risk management and inspection readiness.
• Fosters close working relationships with SSO Clinical Project Managers, VPG Vendor Program Managers, and CDO Trial Data Scientists to deliver on study objectives and strengthen global/local team collaboration.
• Oversees study recruitment and activates mitigation strategies in collaboration with CPMs.
• Ensures proper handling of study close-out activities including site close-out, final drug accountability, and audit readiness of Trial Master File documentation.
• Partners with PSP/COPH to deliver clinical studies in alignment with program strategy.
• Achieves excellence in study operations and management through process improvement in collaboration with the Study Leadership Community Lead/Host and GCO Process, Training, and Compliance.

Essential Requirements

• Bachelor’s degree in life sciences/healthcare (or clinically relevant degree) required. Advanced degree preferred.
• ≥ 4 years of recent involvement in clinical research or drug development in an academic or industry environment spanning Phases I–IV.
• ≥ 3 years of experience in conducting clinical studies (planning, executing, reporting, and publishing) in a global/matrix environment in pharmaceutical industry or CRO, with knowledge of GCP/ICH, FDA/EMA, local/National Health Authority regulations, and Novartis standards.
• Experience in managing people globally in a complex matrix environment preferred.
• Experience developing effective working relationships with internal and external stakeholders.
• Excellent communication and presentation skills (oral and written); ability to communicate at all levels.
• Strong negotiation and conflict resolution skills with an enterprise mindset.
• Strong project management skills with the ability to meet timelines.
• Superior strategic thinking with strong analytical and problem-solving skills.
• Knowledge of the relevant therapeutic area preferred.

About Novartis

Our purpose is to reimagine medicine to improve and extend people’s lives. We strive to be the most valued and trusted medicines company in the world, powered by our people who drive us every day. We are committed to diversity and inclusion in our work environment.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Education and Training

Industries

• Pharmaceutical Manufacturing