Senior Clinical Development Director

3 weeks ago

London, Greater London, United Kingdom Novartis Full time

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, such as submission activities, briefing books, clinical study reports, and more. This role may also lead a section of a clinical program, including an indication, a new formulation, or a specific development phase.

Key responsibilities include providing 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. Additionally, you will drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates.

Requirements include an MD (or equivalent medical degree) and advanced knowledge and clinical training in a medical/scientific area (Rheumatology). 5+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IV, is also required. Furthermore, you should demonstrate ability to establish strong scientific partnership with key partners and possess thorough knowledge of Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory/clinical development processes.

Why Novartis: At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. If you are passionate about helping people with disease and their families, we encourage you to explore this opportunity further.

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