Job Description With over 400 active trials in 5 hub countries, Novartis GDO Trial Management feels privileged to bring together and manage all aspects of clinical trial operations reaching around 50 000 patients worldwide.
We are a proactive learning organization and we place a lot of emphasis on collaboration and individual development. As part of this we are very committed to evaluating the latest digital technologies, always looking to transform trials and improve lives.
TM is in search of those who are passionate about applying their experience to reimagine clinical trial operations and ultimately improve the lives of our team, our organization and our patients.
We are Novartis. Join us and help us reimagine medicine.
The Global Trial Program Head is a senior leader of the GDO TM organization, fosters the right culture within the respective teams and broader matrix environment. As the clinical operational expert, provides strategic insights into the planning and execution of the assigned clinical program(s) to achieve both Business and Corporate objectives. Accountable for end-to-end oversight of budget and resource allocation within assigned clinical program(s). Drives operational excellence through process improvement and knowledge sharing across teams. Enables an empowered organization that can navigate in a matrix environment, adjust quickly to business needs, and deliver on development program(s). Point of escalation for resolution of operational issues within assigned program(s).
Your responsibilities include, but not limited to:
Enterprise Mindset in Teams and Talent Development
1. Builds highly trained and humble talent who are inspired, curious and empowered. Fostering a culture of high performance within a complex matrix.
• Develops and coaches TM associates working on assigned programs including (but not limited to) hiring, performance management and career development.
• Drives functional excellence in compliance with GCPs/SOPs, implementation of best practices and committed to collaboration and knowledge sharing for TM.
2. Strengthens GDO through supporting an excellence-oriented One Novartis culture, agile thinking, fostering innovation, and building best-in-class teams that fully leverage drug development and innovation opportunities within internal systems, programs, processes and tools.
3. Builds center of excellence in clinical trial execution by developing process standards and tools to achieve excellence in trial management. Drives process improvement in collaboration with the Center of Excellence for TM, other Global Trial Program Heads and TM Development Unit (DU) Heads.
4. Leads or key contributor of cross-functional activities and functional initiatives, when appropriate.
5. Able to act as deputy for TM DU Head and role-model values and behaviors for Global Trial Directors and Global Trial Managers
Leader of Clinical Operations for Global Program Team (GPT)
1. Program level planning and execution:
• Core member of the GPT and Global Clinical Team (GCT), serves as single point of contact between GPT and GDO – including point of escalation.
• Key contributor and drives operational strategy within assigned program(s); provides consolidated GDO inputs into Integrated Development Plans (IDP) and Clinical Development Plan (CDP) and any other enterprise-level program plans required.
• Establishes program and trial priorities in alignment with DU/GPT/GCT priorities and advises clinical operational objective setting; drives timely and efficient execution of clinical studies in line with program strategy.
• Within assigned program(s), ensures operational synergy across the indication(s) or compound(s) for best practices and process consistency, and serves as the knowledge source for operational topics.
2. Risk Management:
• Provides inputs and oversight on risk management, quality and compliance for assigned clinical program(s) in conjunction with relevant line functions.
• Responsible for management of program level clinical operation risks and ensures escalation of appropriate program risks and issues to GPT.
3. Resource and Budget Management:
• Ensures optimal resourcing across trials within assigned program(s) to meet business needs according to portfolio prioritization. Collaborates with TM DU Head including coordination of headcount requests and resource alignment with other line functions.
• Oversees life cycle budget including forecast, and annual cost targets for all trials within assign program(s).
• When applicable, ensures resource/budget are accurately recorded in the relevant system(s) (e.g. full accountability for clinical work packages prior to GTD assignment).
4. Active participation within the TM DU Leadership Team and within GDO function as appropriate.
This position can be located at the East Hanover, NJ site and in Basel, Switzerland.