Samenvatting
About the Role
Major accountabilities:
Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols or sub studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
Leading development of clinical sections of trial and program level regulatory documents
Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable
Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
Supporting (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety
As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
Contributing to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training and may be the Program Manager of other associates
Minimum Requirements
Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferred***
Fluent oral and written English
Minimum 7 years experience in clinical research or drug development
Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
Demonstrated ability to establish effective working relationship with key investigators
Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
Strong communication skills with the ability to work in a cross functional and global organization
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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EEO Statement:
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, color, 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.
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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