This position leads the Trial Management franchise organization to ensure strategic planning, execution, and delivery of all global clinical trials across all programs within the assigned franchise. Complete oversight of budget and resource allocation within franchise - including enterprise review of resources across franchises. Single point of contact for assigned franchise and acts as GDO representative on the Development Franchise Leadership Team. Drives operational excellence through process improvement and knowledge sharing across Trial Management function. Develops an empowered organization which can navigate in a matrix environment and adjust quickly to business needs.
1. Drive efficient allocation and resourcing to franchise priorities within broader Trial Management landscape in collaboration with Global Trial Program Heads.
2. Oversight and management of clinical trial budget at franchise level. Core member of the committee responsible for the review and approval of trial budget for assigned franchise.
3. Contribute to shaping the Franchise strategy and translate the Franchise strategy into an operational risk management plan by identifying and appropriately escalating trial and program risk.
4. Drive the mindset of Science of Operations not only in own franchise but as role model and senior leader of the Trial Management leadership team.
5. Serve as single point of contact and trial management representative for assigned franchise for internal/external customers.
6. Proactively identify process improvement and drive excellence in trial operations and management through process improvement in collaboration with other Franchise Heads and Global Head Trial Management.
7. Build best talent and an empowered culture within franchise to foster high performance in a matrix environment. Assess needs of the Trial Management organization to improve the medical/scientific, operational and budget management capabilities in assigned franchise, in alignment with the Global Head Trial Management and other Franchise Heads.
8. Sponsor key talents across the organization to ensure business critical roles and talent continuity for assigned franchise and liaise with other Franchise Heads to secure business continuity across Trial Management.
9. Author/reviewer for relevant SOPs.
10. Core member of the franchise protocol review governance and any other applicable governance groups representing Trial Management.
11. Core Member of the GDO franchise portfolio governance.
12. Chair of leadership team meeting for assigned franchise.
13. Member of the Trial Management Leadership Team.
14. Serve as faculty member for GDO training programs. May participate in or lead cross-functional process improvement initiatives.
15. May deputize for the Global Head Trial Management EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements Degree:
Bachelor degree is required. Discipline in a life science or healthcare is strongly preferred.
Advanced degree in life science/healthcare preferred (PhD/MD preferred).
• 15+ years of pharmaceutical clinical drug development experience. (with 10 years minimum in global clinical drug development operations)
• 10+ years people management, including leadership of managers and management in a matrix environment. Experience in managing people globally required.
• Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs.
• Strong management, interpersonal and problem solving skills.
• Extensive knowledge of clinical development process, regulatory requirements and Good Clinical Practice (GCP). Novartis experience in these areas is preferred.
• Proven track record in trial operations process improvement(s).
• Considerable organizational awareness, including significant experience in matrix and high pressure environments.
• Strong knowledge of appropriate therapeutic area preferred.