1 in 5 men and 1 in 6 women worldwide develop cancer during their lifetime according to the World Health Organization. In Oncology Medical Affairs we are working tirelessly to bring innovative cancer treatments to patients with our presence in four oncology treatment platforms.
Leads planning and management of the Cell and Gene Program from an end-to-end trial management perspective to achieve Oncology Medical Affairs (OMA), Global Medical Affairs (GMA), GMA Franchise, Global Clinical Team (GCT) and Clinical Trial Team (CTT) objectives. Complete oversight of budget and resource allocation within assigned trial(s). Oversight of budget and resource allocation within the Cell and Gene Program – including broader review of resources in collaboration with the GMA Franchise Clinical Operations Head (GFCOH). Drives operational excellence through process improvement and knowledge sharing within the program and/or trial. May act as point of escalation within Cell and Gene Program.
• Oversight on Cell and Gene Program level clinical operations activities
• Oversight of cell manufacturing slot management activities
• Drive timely and efficient program execution according to the approved Integrated Evidence Generation Plans
• Coordinate program level activities in collaboration with program managers
• Budget and Resource Management Program Level Support
• Ensure Investigator Initiated Trials and Managed Access Programs are conducted appropriately and timely in accordance with SOPs and in collaboration with the regions and countries
• Drive process improvement in collaboration with in clinical operations team
• Build best talent and an empowered culture within Cell and Gene Program to foster high performance in a matrix environment.
• Lead and manage the global cross-functional CTT to ensure deliverables are met within the established timelines, budget and quality/compliance standards; accountable for representation at all internal meetings related to the clinical trial: chair the routine CTT meetings, participate and report study progress and issues/resolution at the GMA Governance Board Meetings and Portfolio Review Meetings.
• Leads the cross-functional development of global clinical trial protocol(s) into efficient, high quality, executable clinical protocols
• Trial planning, execution and close-out
• Author/reviewer for relevant SOPs
• Support establishing and maintaining close and effective relationship with Clinical Operations in OMA, Global Drug Development, and Pharma.
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.
• Bachelor’s degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred.
• ≥8 years of pharmaceutical clinical research experience
• ≥5 years people management and development experience required, this may include management in a matrix environment. Global people management experience is desirable
• Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials. Extensive knowledge of clinical research, GCP and clinical project management. Novartis experience in these areas is preferred.
• Organizational awareness, including significant experience working cross-functionally and in global teams.
• Strong knowledge of appropriate therapeutic area preferred, i.e. CAR-T clinical research.
East Hanover, NJ
Research & Development