Clinical Development Medical Director - Renal

Overview Summary : As a Clinical Development Medical Director, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g., submission activities, briefing books, clinical study reports, etc.) and / or a large, complex trial, under the leadership of the Global Program Clinical Head (GPCH). May also lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).

Major accountabilities Provide clinical leadership and medical strategic input for deliverables in the assigned project / program. Deliverables may include sections of individual protocols consistent with the clinical development plan (CDP), data review, program specific standards, clinical components of regulatory documents / registration dossiers, and publications (e.g., investigator brochures, briefing books, safety updates, submission dossiers, and responses to health authorities)

Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors, and regional / country medical associates

Oversee / conduct medical and scientific review of trial data with Clinical Scientific Expert (CSE). May be the Program Manager of other associates (e.g., CSE). May function as study medical monitor

Support GPCH in ensuring overall safety of the molecule. May be a core member of the Safety Management Team, and supports program safety reporting (e.g., PSURs, DSURs, and safety related documents) in collaboration with Patient Safety

Support the Clinical Development Head by providing medical input into CDP and clinical trial package reviews and contributing / driving development of disease clinical standards for disease areas

Provide support to the GPCH or CDH in interactions with external partners (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (e.g., clinical trial team, Medical Affairs, Commercial, Health Economics & Outcomes Research), and decision boards)

Work with BR (Novartis Biomedical Research) / Translational Medicine to drive transition of early development projects to Transition Decision Point and with Business Development, including target identification and due diligences

Ensure career development of Program Reports and clinical colleagues through active participation in performance management and talent planning processes. Provide on-boarding, training, & mentoring support

Contribute to medical / scientific training of relevant Novartis stakeholders on the disease area and compound / molecule. May serve as speaker for Global Clinical team

Minimum requirements MD (or equivalent medical degree) required. Training in nephrology preferred

Medical Board certification preferred. 4+ years Clinical practice experience (including residency) preferred

Possess advanced knowledge and clinical training in a medical / scientific area (e.g., internal medicine or sub-specialty) required

5+ years of experience in clinical research or drug development from the pharmaceutical / biotechnology industry, preferably spanning clinical activities in phases I through IV

3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global / matrixed environment

Showcase advanced knowledge of assigned therapeutic area

Demonstrate ability to establish strong scientific partnership with key partners

Need thorough knowledge of Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory / clinical development processes

People management experience preferred, especially at the global level (this may include management in a matrixed environment)

About the company Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Benefits and rewards information is available in the Novartis benefits handbook.

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