Senior Clinical Development Medical Director - RheumatologyJob ID: REQ-10017739
Location: United Kingdom
SummaryAs a Clinical Development Medical Director - Rheumatology, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.
About the RoleThe Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g., submission activities, briefing books, clinical study reports) 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, including sections of individual protocols, data review, program-specific standards, and clinical components of regulatory documents.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).Support GPCH in ensuring overall safety of the molecule and may be a core member of the Safety Management Team.Provide medical input into CDP and clinical trial package reviews, contributing to the development of disease clinical standards.Support the GPCH or CDH in interactions with external partners and internal stakeholders.Work with BR (Novartis Biomedical Research)/Translational Medicine to drive transition of early development projects.Ensure career development of Program Reports and clinical colleagues through active participation in performance management processes.Contribute to medical/scientific training of relevant Novartis stakeholders.Minimum Requirements:MD (or equivalent medical degree) required; training in Rheumatology preferred.4+ years Clinical practice experience (including residency) preferred.Advanced knowledge and clinical training in Rheumatology required.5+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry.3+ years of contribution to conducting clinical trials in a global/matrixed environment.Thorough knowledge of Good Clinical Practice, clinical trial design, and regulatory/clinical development processes.People management experience preferred, especially in a matrixed environment.Commitment to Diversity and Inclusion: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 to achieve breakthroughs that change patients' lives.
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