Global Program Clinical Head (Early GPCH NS)
Join to apply for the Global Program Clinical Head (Early GPCH NS) role at Novartis
Global Program Clinical Head (Early GPCH NS)
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Join to apply for the Global Program Clinical Head (Early GPCH NS) role at Novartis
Summary
As Global Program Clinical Head (GPCH), you are the clinical lead for Neuroscience, leading clinical development and contributing to overall strategy in collaboration with other functions, to ensure the development and implementation of the Clinical Development plan. You will lead a cross-functional team of specialists and align early development plans with the overall strategy, oversee licensing evaluations, and develop and execute the disease area strategy.
Summary
As Global Program Clinical Head (GPCH), you are the clinical lead for Neuroscience, leading clinical development and contributing to overall strategy in collaboration with other functions, to ensure the development and implementation of the Clinical Development plan. You will lead a cross-functional team of specialists and align early development plans with the overall strategy, oversee licensing evaluations, and develop and execute the disease area strategy.
About The Role
Your Key Responsibilities:
* Responsible for clinical input to support Business Development & Licensing (BD&L) activities.
* The GPCH works to ensure early development plans and proof of concept studies are aligned with Development strategy.
* 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 more 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 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 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
Role Requirements
Essential Requirements:
* MD, or PH. D degree with 10+ years’ experience 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 ability to innovate in clinical development study designs, provide relevant evidence to decision-makers and to 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 process
* Demonstrated ability to establish strong scientific partnership 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 pharmaceutical or biotech industry
Desired Requirements
* MD or equivalent, MD or MD/PhD in Neurology, Experience in Cell & Gene, Rare or Neuromuscular, Neurodegenerative diseases, Neuroinflammation of interest
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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Seniority level
* Seniority level
Executive
Employment type
* Employment type
Full-time
Job function
* Job function
Other
* Industries
Pharmaceutical Manufacturing
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