Global Program Clinical Head - Neurosciences
Job ID REQ-10032147
Jan 08, 2025
Summary
With over 60 years of 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, neurodegeneration, 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.
About the Role
The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.
As the leader of Global Clinical Team(s) (GCT), the GPCH is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements, market access, and owns the risk-benefit assessment for the program(s). The GPCH contributes to the disease area strategy.
Your responsibilities include, but are not limited to:
* Leading the development and execution of the clinical strategy in full development (Phase 2b and 3) and developing an endorsed Clinical Development Plan (CDP) in line with the Target Product Profile (TPP) designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs.
* Responsible for clinical input to support Business Development & Licensing (BD&L) activities.
* Might serve as the Clinical Development Representative to drive the transition of pre-PoC (Proof of Concept) projects to Transition Development Point (TDP).
* Drive creation and implementation of Clinical Development to support decision analysis and optimal resource allocation in program(s).
* Lead a cross-functional team (Global Clinical Team GCT) 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 expert, lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (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 the 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 implement publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing, and provide input into key external presentations.
What you’ll bring to the role:
* MD or Ph.D. degree with 10+ years’ experience (6+ years for MDs) in clinical research or drug development in an industry environment spanning clinical activities in Phases I-III/IV, including submission dossiers.
* A passion for Neuroscience.
* Advanced expertise in Neuroscience with the ability to innovate in clinical development study designs, provide relevant evidence to decision-makers, and interpret, discuss, and present clinical trial or section program level data.
* Detailed knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development processes.
* Demonstrated ability to establish strong scientific partnerships with key stakeholders.
* Demonstrated leadership and management skills with a documented track record of delivering high-quality projects/submissions/trials in a global/matrix environment (including remote) in the pharmaceutical or biotech industry.
* MD or equivalent (preferred).
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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? Learn more
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