Senior Clinical Development Medical Director - Renal
Job ID REQ-10052215
May 20, 2025
Summary
The Senior* Clinical Development Medical Director (Sr* CDMD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As Senior/CDMD in the Renal TA, you will oversee the clinical development for the assigned programs and drive execution of the clinical development plan. Additionally, you will enable an empowered organization capable of navigating a matrix environment and adapting quickly to business needs.
About the Role
Major accountabilities:
Your responsibilities will include, but are not limited to:
* Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
* Leading development of clinical sections of trial and program-level regulatory documents.
* Driving execution of the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable.
* Supporting the (Senior) Global Program Clinical Head (GPCH) in ensuring the overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues.
* Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP), and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas.
* As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
* May work with NIBR (Novartis Institute of Biomedical Research/Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing), including target identification and due diligences, along with other medical matters as needed.
Qualifications:
* MD or equivalent medical degree is required, with advanced knowledge and clinical training in a medical/scientific area; clinical practice experience of at least 4 years (including residency) and board certification or eligibility in the disease area preferred.
* Minimum of 7 years of experience in clinical research or drug development (Senior 10+ years preferred).
* Experience in academic clinical research or industry spanning clinical activities in Phases I through IV is required.
* At least 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (planning, executing, reporting, publishing) in a global/matrix environment in the pharmaceutical industry.
* Working knowledge of disease area, ability to interpret, discuss, and present efficacy and safety data, and understand basic and clinical scientific research reports.
* Proven ability to establish effective scientific partnerships with key stakeholders.
* Knowledge of GCP, clinical trial design, statistics, and regulatory processes.
* Previous global people management experience is preferred, including management in a matrix environment.
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