60! With 60-year history in neuroscience, Novartis brought landmark therapies to patients with Multiple Sclerosis, Alzheimer's disease, Parkinson's Disease, Epilepsy, Depression and Migraine. We have a world-class pipeline in neuro-inflammation, neuro-degeneration, psychiatric and neuromuscular diseases. Our holistic R&D approach includes cutting edge molecules, comprehensive approaches to technology, biomarker and digital therapeutics to propose better solutions for patients worldwide.
As Global Program Clinical Head (GPCH) you are the clinical lead of a Neuroscience full development product and will be responsible for the clinical assessment of internal Novartis Institute for Biomedical Research (NIBR) early clinical programs and external assets (Business Development & Licensing - BD&L) across neurosciences indications.
As a key member of the Global Program Team, you will contribute to the overall strategy in collaboration with relevant other functions such as Regulatory Affairs, Market Access and others. You are responsible for developing and ensuring the implementation of the Clinical Development plan and leading a cross functional team of specialists such as Medical Directors, Trial Directors, Safety Leaders, Biostatisticians and Regulatory Directors. In addition, you will contribute to the development and execution of the disease area strategy.
What you'll be doing: * Responsible for clinical input to support Business Development & Licensing (BD&L) activities * Serve as the Clinical Development Representative to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP) * Contribute to Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs. * Drive creation and implementation of Clinical Development to support decision analysis and optimal resource allocation in program(s). * Lead a cross functional team through the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator's Brochures, Clinical Study Reports, regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency. * As the medical professional, lead interactions with external partners (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal partners (e.g., Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcomes Research), and internal decision boards * Together with Patient Safety, ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance. * Support registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s) * Plan and execute publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing, and provide input into key external presentations