Global Clinical Development Leader
Vor 2 Tagen
The Global Program Clinical Head is a critical role within Novartis, responsible for leading the development and execution of clinical strategies for one or more clinical programs across indications. This position requires a strong understanding of clinical development, regulatory requirements, and market access.
Key Responsibilities:- Lead the Global Clinical Team, representing Clinical Development on the Global Program Team
- Develop and execute clinical strategies, including the creation of clinical components of key documents such as Clinical Trial Protocols, Investigator's Brochures, and Clinical Study Reports
- Ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance
- Lead interactions with external stakeholders, including regulatory authorities, key opinion leaders, and patient advocacy groups
- Develop and maintain strong scientific partnerships with key stakeholders
- Deliver high-quality projects, submissions, and trials in a global/matrix environment
- MD or equivalent (required)
- PhD (preferred)
- 5 years professional experience as MD and a minimum of 10 years of experience with clinical drug development in an industry environment
- Advanced knowledge of assigned therapeutic area, with the capability to innovate in clinical development study designs
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
- Demonstrated leadership and management skills
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