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Salon Recruitment
,
London, Greater London
Clinical Development Director - Rheumatoid Arthritis
Overview
We're looking for a candidate to this position in an exciting company. Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible time frame Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s) Demonstrated experience using new learning and digital tools to create innovation in other areas Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules Demonstrated experience integrating genetic data to inform and guide clinical protocols Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions.