Summary
Oversee the execution and delivery of a portfolio of GCO-supported clinical studies for Novartis, involving diverse complexities and priorities, in accordance with the Clinical Development Plan (CDP) and Operational Execution Plan (OEP). The portfolio consists of clinical trials of similar types within a Study Leadership community.
Provide developmental support and guidance to Study Leaders within the community, assisting in stakeholder navigation and operational aspects of clinical trials, in compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and country-specific regulations. This encompasses all operational facets of a clinical trial.
This position is hybrid, based in Basel, Switzerland.
About The Role
Major accountabilities include:
1. Leading a Study Leadership community, including people management responsibilities within the organization.
2. Promoting operational excellence and knowledge sharing across studies.
3. Fostering an empowered, psychologically safe environment capable of navigating a matrix organization, learning, and adapting quickly to changing business needs.
4. Managing resource allocation within the assigned community and overseeing the execution and delivery of a portfolio of clinical studies.
5. Leading the Clinical Trial Team (CTT) independently alongside the Clinical Study Lead (CSL), in collaboration with the Clinical Operations Program Head (COPH), to deliver multiple complex global studies, promoting learning, performance, and operational excellence through an agile mindset and team model.
6. Acting as the CTT product co-owner, responsible for delivering the operational strategy according to established protocols.
7. Guiding planning and decision-making at the study level to ensure delivery per the OEP and clinical protocol.
8. Fostering an agile culture within assigned studies to achieve sprint goals, maximize collaboration, and minimize dependencies for long-term impact.
Education and Experience
1. Bachelor’s degree in life sciences, healthcare, or a clinically relevant field; advanced degrees are preferred.
2. Fluent in English, both oral and written.
3. At least 8 years of recent involvement in clinical research or drug development, covering Phases I-IV studies of medium to high complexity.
4. Minimum of 5 years of experience contributing to all aspects of conducting complex clinical studies in a global/matrix environment, with knowledge of GCP/ICH standards, and regulatory authorities like FDA and EMA.
5. At least 5 years of recent people management experience in a complex, global matrix environment; experience with virtual teams is highly preferred.
6. Proven ability to lead teams, develop capabilities, and build effective stakeholder relationships.
7. Excellent communication and presentation skills at all organizational levels.
Novartis is committed to creating an inclusive, diverse work environment that reflects the patients and communities we serve.
Why Novartis: Helping people with disease and their families requires more than science; it requires a passionate community. Join us to collaborate, support, and innovate to change lives. Learn more: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right role? Sign up to stay connected and learn about future opportunities: https://talentnetwork.novartis.com/network
Benefits and Rewards: Discover how we support your growth: https://www.novartis.com/careers/benefits-rewards
#J-18808-Ljbffr