Clinical Development Director
Clinical Development Director
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$ 204400 - 379600
1 Vacancy
Job Description
Band
Level 6Job Description 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 agreementsJob Description
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.
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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and 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 in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Clinical Trials Cross-Functional Teams Data Analysis Data Monitoring Drug Development Drug Discovery Medical Research Medical Strategy People ManagementRequired Experience:
Director
Employment Type
Full-Time
