*Senior Clinical Development Director - Renal

*Senior Clinical Development Director - Renal

Job ID REQ-10050165

May 21, 2025

Summary

The *Senior/Clinical Development Director (*Sr. CDD) is the clinical/scientific expert and, if assigned, the clinical development lead of a section of a global clinical program and/or trial. This could involve an indication, a new formulation, or a specific development phase, or a large, complex trial, under the leadership of the GPCH. The *Sr. CDD may also have a team leadership role for sections of clinical programs and/or global clinical trials, depending on the size, nature, and complexity.

About the Role

Major accountabilities:

1. Supports and, if assigned, leads the delivery of all clinical deliverables in the assigned section of a clinical program, including development strategies, clinical protocol sections, data review, regulatory documents, and publications.
2. Contributes to and, if assigned, leads the development and delivery of clinical sections of regulatory documents such as Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to health authorities.
3. Drives execution of the clinical program section in partnership with global functions, including clinical operations, trial leaders, data management/analysis, and regional/country clinical development associates.
4. Ensures ongoing clinical and scientific review of trial data.
5. Collaborates with data management and statistics teams to ensure data quality and proper analysis of clinical results.
6. May serve as Program or Function Manager for associates.
7. Supports GPCH in assessing the risk-benefit profile of the molecule, may be a core member of the Safety Management Team, and supports safety reporting activities.
8. Member and potentially co-lead the Global Clinical Team (GCT), representing the section in meetings and external forums.
9. Provides clinical/scientific input into IDP/CDP and CTP reviews, and contributes to developing disease clinical standards. May assume additional TA responsibilities as directed by the CDH.
10. Requires an advanced degree in life sciences or healthcare (PharmD, PhD preferred), with ≥ 10 years in clinical research and global drug development, including ≥ 5 years in clinical trials in a pharmaceutical environment, especially late-phase development.
11. Possesses strong scientific writing skills, experience with regulatory submissions, and the ability to analyze and interpret scientific data.
12. Knowledge of the therapeutic area is preferred, along with demonstrated ability to establish scientific partnerships.

* Final job title and responsibilities will align with the candidate's expertise.

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