Zusammenfassung
The Study Director is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve global objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversee budget and people allocation within assigned study/studies. The Study Director promotes operational excellence through process improvement 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. The Study Director is accountable for resolution of study management operational issues and impediments within assigned study/studies.
About the Role
Key Responsibilities:
- Lead the clinical trial team in collaboration with the Clinical Operations Program Head (COPH), ensuring delivery of complex global studies
- Create effective CTT dynamics and achieve performance, priorities, and communication in close collaboration with CTT sub-team leaders
- Guide planning and decision making at the study level, ensuring assigned clinical studies are delivered per the Operational Execution Plan (OEP) and clinical study protocol.
- Foster an agile culture within assigned studies, working to achieve sprint goals and cycles, thereby maximizing collaboration and minimizing dependencies.
- Oversees study recruitment and responsible for activating mitigation strategies.
- Achieves excellence in study operations and management through process improvement.
Essential Requirements:
- Bachelor's degree in life sciences/healthcare (or a clinically relevant degree). An advanced degree is preferred.
- At least 7 years of recent experience in clinical research or drug development spanning clinical activities in Phases I through IV studies of medium to high complexity
- At least 3-5 years of recent contribution to and accomplishment in all aspects of conducting clinical studies (e.g. planning, executing, reporting and publishing) of medium to high complexity in a global matrix environment within the pharmaceutical industry or a contract research organization.
- At least 3 years recent people management in a complex matrix environment. Experience in managing people strongly preferred.
- Proven abilities in negotiation and conflict resolution, strategic thinking, strong analytical, and problem-solving skills.
- Experience in developing effective working relationships with internal and external stakeholders
- Excellent communication and presentation skills (both oral and written), with the ability to communicate across all levels.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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