769 million patients were impacted by Novartis products in 2020. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
The Head, US Clinical Operations Excellence is accountable for strategic and operational leadership of all US Pharma Innovative Phase IIIb/IV clinical trials, HEOR prospective registry trials, Investigator Initiated Trials (IITs), Managed Access Programs (MAPs), Post trial drug access programs, Drug Supply Management, including oversight of a separate drug packaging and distribution COE facility, Biometrics, and US Sourcing activities.
Your responsibilities will include:
*Clinical Trial Oversight - Oversee key clinical operations activities for US Medical Affairs Phase IIIb/IV clinical deliverables, Global development post trial drug access, collaborative agreements with external health associations and HEOR prospective registry studies to ensure programs are developed and executed in an effective manner and in compliance with all external regulatory standards and internal policies, SOPs and standards. Partner with Medical Units to ensure operational excellence. *Clinical Trial Innovation - Design and drive simplified and innovative trial design strategies that improve efficiencies and ease patient and physician burden, i.e. virtual trials, wearables, etc. Responsible to lead and develop novel approaches related to study design and execution, site identification and drug access. *Forecasting/Budget Management - Oversee preparation of clinical program and trial budgets, forecasts and personalization as part of strategic plan. Accountable for the U.S. Pharma clinical trial study program, external collaborative programs and drug distribution COE center budgets, and reporting to Sr. Management and Finance. Responsible for contract negotiations for all US Medical tactics, including Medical Affairs clinical trials, IITs, HEOR Registry and Non-Interventional studies, Advisory Boards, and Consultancy Agreements. Responsible for collaboration with US legal and patent departments to lead the resolution of complex contractual issues within the framework of the US legal and compliance requirements. *Drug Supply Management - Responsible for US drug supply management activities for all US Phase IIIb/IV, IIT, and MAP programs. Oversee the management of drug packaging and distribution COE facility. Lead partnership with Global DSM, TechOps, NIBR, Development QA, and external drug supply vendors to secure and release clinical product. Process evaluation and optimization to analyze use of available internal systems and design/improve drug supply processes within the US. *Compliance/Auditing - Facilitate internal clinical audits and HA inspections as required. Assist in audit response and implementation of corrective actions following audits and inspections in relationship with Quality Assurance. Ensure all Main advisor regarding potentially significant quality/compliance issues. *Team Leadership/Talent Development/Culture - Create deep talent pipeline by identifying, attracting and developing a best in class Clinical Development & Medical Affairs team. Provide effective coaching and development to team members to build technical and leadership skills in line with Novartis Leadership aspiration. Cultivate a diverse and inclusive, high performance environment that supports our unbossed, curious, and inspired culture. *Enterprise and Functional Leadership - Serve as member of US CDMA Leadership team, contributing to enterprise-wide initiatives. Full member of the PDAB committee that endorses drug development strategy for US Pharma.