Summary
- Oversees the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements
About the Role
Major accountabilities:
- Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program and/or programs.
- Ensure effective cross-functional communications to align with global strategy -Leads development of clinical sections of trial and program level regulatory documents -Drives execution of the section of the clinical program in partnership with global line functions.
- Supports the clinical research leaders by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas -Acts as the medical expert, engages interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders -Contributes to medical/scientific training of relevant Novartis stakeholders.
- May serve as speaker for franchise medical/scientific training -May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) -Develops high potential talents for succession positions to ensure business continuity.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- Achievement of unit objectives -Delivery of Clinical Trials to quality standards and agreed timelines -Adherence to Novartis policy and guidelines and external regulations.
Minimum Requirements:
Work Experience:
- Strategy Development.
- Project Management.
- Collaborating across boundaries.
- Operations Management and Execution.
- Representing the organization.
Skills:
- Clinical Trials.
- Cross-Functional Teams.
- Data Analysis.
- Data Monitoring.
- Drug Development.
- Drug Discovery.
- Medical Research.
- Medical Strategy.
- People Management.
Languages :
- English.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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.
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.
