Global Program Clinical Head
Global Program Clinical Head
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Job Description
Job Description Summary
With over 60 years history in neuroscience Novartis brought landmark therapies to patients with Multiple Sclerosis Alzheimers disease Parkinsons Disease Epilepsy Depression and Migraine. We have a worldclass pipeline in neuroinflammation 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
As Global Program Clinical Head (GPCH) you are the clinical lead of Neuroscience full development product. 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 will develop 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. The GPCH works to ensure early development plans and proof of concept studies are aligned with Development strategy and leads licensing evaluations for Clinical Development for the therapeutic area. In addition you will lead the development and of the disease area strategy.
What youll be doing:
- Responsible for clinical input to support Business Development & Licensing (BD&L) activities
- Serve as the Clinical Development Representative to drive transition of prePoC (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 Investigators 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 postmarketing surveillance.
- Support registration market access commercialization and maintenance of product licenses (e.g. Core Data Sheet Periodic Safety Update Report clinical benefitrisk 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 youll bring to the role:
- MD or PH. D degree with 10 years experience in clinical research or drug development in an industry environment spanning clinical activities in Phases IIII/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 decisionmakers 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
Desirable:
- MD or equivalent MD or MD/PhD in Neurology Experience in Cell&Gene Rare or Neuromuscular diseases Neuroinflammation of interest (preferred).
This is a hybrid role and it can be based in Basel London or Barcelona.
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/about/strategy/peopleandculture
Benefits and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: https://www.novartis/careers/benefitsrewards
Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race colour religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Skills Desired
Budget Management Clinical Trials Coaching Compliance CrossFunctional Teams Leadership People Management Risk Management Risk Monitoring StrategyRequired Experience:
Exec
Employment Type
Full-Time
