Résumé
About the Role
Job Description
Are you an experienced Drug Development Leader looking for an exceptional opportunity to make a global impact? Novartis is seeking a Global Program Clinical Head for In-market Brands to join our team in Switzerland. As a leader in the industry, Novartis is dedicated to discovering innovative solutions that improve patients' lives worldwide.
Responsibilities:
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 NIBR clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
Post-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
Requirements:
MD, PhD, or PharmD degree required, specialization in a subspecialty preferred
Minimum 10 years involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
Sophisticated knowledge of assigned therapeutic area preferred, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
Strong leadership skills with the ability to effectively collaborate and influence cross-functional teams
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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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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