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Salon Recruitment
,
London, Greater London
Clinical Development Director Respiratory Eos Disease
Overview
We're looking for a candidate to this position in an exciting company. As Clinical Development Director – Respiratory Disease, you will lead phase 2A studies through to registrational programs while interfacing with colleagues in a leading Respiratory company with a portfolio of proven medicines for Respiratory Disease. This role will provide you the opportunity to lead key activities to progress your career. Job purpose and key responsibilities:Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development 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 timeframe 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 Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area 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.