Clinical Development Medical Director - Renal

Clinical Development Medical Director - Renal

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Summary
The Clinical Development Medical Director (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 CDMD in the Renal TA, you will oversee clinical development for the assigned programs and drive the execution of the clinical development plan. You will also 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 the development of clinical sections of trial and program-level regulatory documents.
• Driving the 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 (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 interactions with external and internal stakeholders and decision boards.
• Collaborating with NIBR to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences, as needed.

Minimum Requirements

• MD or equivalent medical degree with advanced knowledge and clinical training in a medical/scientific area; clinical practice experience of 4+ years (including residency) and board certification or eligibility in 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.
• At least 2 years of contribution to and accomplishment in all aspects of conducting clinical trials in a global/matrix environment.
• Working knowledge of disease area, ability to interpret efficacy and safety data, and understanding of scientific research reports.
• Ability to establish effective scientific partnerships with key stakeholders.
• Knowledge of GCP, clinical trial design, statistics, and regulatory processes.
• Previous global people management experience preferred, including management in a matrix environment.

Novartis is committed to diversity and inclusion. If you need reasonable accommodation during the recruitment process, please contact diversity.inclusion_ch@novartis.com with your request and contact information, including the job requisition number.

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Seniority level

• Director

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing

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