This position within R&Ds Early Development (ED) organization is a highly strategic and influential one which will be pivotal in strengthening the quality and progress of CSLs early R&D pipeline. The role is focused on providing crucial clinical and translational medicine input to early stage R&D projects (typically from mid-stage Research up to clinical proof-of-concept). The medically-qualified candidate for this role will be based at CSLs King of Prussia location.
• Provide medical and disease area knowledge in support of projects in the early R&D pipeline, working closely with Therapeutic Area leads within CSD.
• Provide clinical leadership for Research projects entering Product Development and GLP toxicology stage through to proof-of-concept. Oversee and develop innovative early clinical development (including translational science and experimental medicine) strategies to evaluate functional relevance of targets in human disease.
• Devise, lead and implement innovative and industry-leading early clinical development plans, ensuring cross-functional engagement and alignment of strategies with Commercial needs.
• Lead clinical input into Target Product Profiles for early projects.
• Form and lead a Clinical Development Team for a pre-FIH program.
• When assigned, lead CSLs FIH governance process and its associated FIH Committee.
• Work closely alongside the Clinical & Translational Science group to ensure that clinical assay and Translational Science/biomarker plans receive appropriate clinical input and peer review and are endorsed and integrated into the Clinical Development Plan. Support qualification of PD/disease markers for early assessment of clinical outcomes.
• Work closely with experts within CP&P to have pharmacokinetic and pharmacometric aspects of assigned projects fully covered and integrated into clinical plans.
• Conduct of early clinical (including FIH) studies: ensure close cross-functional engagement in the planning and enabling of these studies.
• Determine the strategy for the selection and use of relevant external advisors and vendors as needed for the execution of an early clinical study.
• Lead the design and protocol development for an early clinical study.
• Lead clinical contributions to regulatory documents, including Investigator Brochures and dossiers for Agency interactions. Leads the resolution of clinical queries from regulatory agencies for assigned studies.
• Lead the high quality review and interpretation of study outcomes for assigned studies and oversees the presentation thereof in clinical study reports, related study documentation, and to varied team and governance audiences.
• Maintains a strong understanding and awareness on new and emerging medical developments. Liaises with the internal and external medical community to follow developments within disease areas of interest to R&D.
•MD or M.D./Ph.D, Board Certified
•A minimum of 4 years post-medical graduation with at least 2 years post-graduate research experience.
•Proven ability to meet the clinical requirements set out in Responsibilities above.
•Proven ability in clinical research methods.
•Functional managerial or leadership experience.
•Laboratory research methods.
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