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Join to apply for the Clinical Development Director - CV role at Novartis Ireland Summary
The Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective.
As a CDD in the CV TA, you will have oversight of the clinical development for the assigned programs and drive the execution of the clinical development plan.
In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
Summary
The Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective.
As a CDD in the CV TA, you will have oversight of the clinical development for the assigned programs and drive the execution of the clinical development plan.
In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
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
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Development Director • Dublin, Ireland