Clinical Development Director - Renal

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Summary

The Clinical Development Director (CDD) is the clinical / scientific expert and the clinical development lead of a section of a global clinical program and / or trial. This may include an indication, a new formulation, a specific development phase, or a large, complex trial, under the leadership of the GPCH. The CDD may also have team leadership responsibilities depending on the size and complexity of the clinical programs or trials.

About The Role

Major accountabilities :

• Supports and leads the delivery of clinical deliverables in the assigned section, including development strategies, protocol sections, data review, regulatory documents, and publications.
• Contributes to and leads the development of clinical sections of regulatory documents such as Investigator’s Brochures, briefing books, safety updates, and submission dossiers.
• Drives execution of clinical programs in collaboration with global line functions, clinical operations, trial leaders, and data management teams.
• Ensures ongoing review of clinical trial data for scientific accuracy and integrity.
• Collaborates with data management and statistics teams to ensure data quality and proper analysis.
• May manage clinical associates or teams.
• Supports overall risk-benefit assessment of the molecule, safety reporting, and safety management activities.
• Represents the clinical section in global team meetings and external stakeholder engagements.
• Provides scientific input into development plans and standards, and may take on additional therapeutic area responsibilities.

Minimum Requirements

Why Novartis

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Benefits and Rewards

Details available in the Novartis Life Handbook :

Commitment To Diversity And Inclusion

We are committed to creating an inclusive, diverse work environment that reflects the communities we serve.

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Seniority level : Director

Employment type : Full-time

Job function : Research, Analyst, and Information Technology

Industry : Pharmaceutical Manufacturing

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