Global Program Clinical Head
Vor 2 Tagen
Job Description 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.
Job Description
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 GCT and representing Clinical Development on the Global Program Team (GPT).
- Leading the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmaco-economic dossiers) with high quality and consistency with Integrated Development Plan (IDP) and Target Product Profile (TPP).
- Supports 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).
- May serve as the Clinical Development Representative on Biomedical Research clinical/project teams to drive the transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP).
- Leading the development and execution of the clinical strategy. Developing an endorsed (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.
- Where applicable, supporting Business Development & Licensing (BD&L) activities.
Minimum requirements:
- MD or equivalent (preferred), PhD, or PharmD degree required, specialization in a subspecialty may be needed.
- Advanced clinical training/knowledge in Neurosciences preferred with 6 years (MD or equivalent).
- 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through 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 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 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 pharmaceutical or biotech industry.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
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.
Skills Desired
- Budget Management
- Clinical Trials
- Coaching
- Compliance
- Cross-Functional Teams
- Leadership
- People Management
- Risk Management
- Risk Monitoring
- Strategy
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