About the Role
As part of the Neuroscience (NS) departments at Novartis, you will help to develop therapies for patients with neuroimmunological disorders including multiple sclerosis.
You will provide medical and scientific leadership and expertise in a role that significantly affects the entire Novartis NS pipeline. You will drive the success of both early and late stage global programs. You will provide scientific expert assessments and support for in-licensing opportunities, including due diligences.
Your responsibilities will include:
1. Translational Medicine (early clinical projects):
• Develop high value decision-strategies for the Translational Medicine component of drug development projects from Research to clinical Proof of Concept or Proof of Mechanism in a single or multiple indications.
• Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies), and other documents such as investigators brochures.
• Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study
• Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups)
• Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches
2. Translational Medicine (late-stage clinical projects):
In collaboration with the respective Translational Medicine Therapeutic Area Head:
• Responsible for implementing studies during the Proof of Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in Proof of Concept studies.
• Communicate clinical team matters to Global Project Teams, relevant BioMedical Research and Development boards, and other Novartis Boards as required.
• Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders
• The work environment is in a matrix structure with cross-functional members from Translational Medicine, Biomedical Research and Development.
Impact of this role?
• Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds
• This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof of Concept mechanism, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions
• As a recognized specialist in Neuroimmunology, you drive the project team clinical strategy. Works globally across various Novartis divisions as well as country organizations as appropriate
Diversity & Inclusion / EEO
• Medical Degree and advanced training in neuroimmunology
• An expertise in translational or laboratory research. PhD preferred but not required
• Record of drug submissions / approval and / or high quality publications in international scientific journals.
• Previous relevant & significant clinical study experience: either from pharma/biotech leading early phase clinical trials; a senior role within a CRO responsible for managing the medical relationship with Sponsors; from a relevant academic medical center with PI & co-PI clinical trial experience.
• Business fluent in English (written and spoken)
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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