Sr. Clinical Development Director - Nephrology

GlaxoSmithKline ,
Brentford, Greater London
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Job Description

Clinical Development Lead sought for phase 3 program in Renal disease. As Sr. Clinical Development Director - Nephrology you will lead clinical program and integrate pivotal studies for anemia of chronic kidney disease. The position includes creating and executing the clinical development strategy for emerging pipeline of renal medicines. Work with colleagues in Specialty Medicines with Clinical Sciences, which includes Neurosciences, Infectious Disease, Rare Disease, Cardiovascular, Metabolic and Renal disease. This role will provide you the opportunity to lead key activities to progress your career. Job Purpose and Key Responsibilities: * Providing integrated and innovative clinical development strategy to support the creation and management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development * Strategic Leadership: Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the 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 * Establishing expeditious clinical development timelines, incorporating 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 and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development * Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring and potential direct line management Scientific Leadership, Direction and Strategy: * Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s). Leads selected clinical development projects for products/franchise of compounds * Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development * Leading and positively interfacing with and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need * Integrating inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Medicine Profile. Accountable for the clinical components of the Medicine Profile. * Accountable for risk/benefit of the asset. Actively leads and makes decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate * Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit * Anticipating problems and proactively seeking input from other teams' members/functional lines within R&D. Uses scientific/operational expertise to solve study and/or project related problems * Accountable for the evaluation of clinical study/program probability of technical success (PTS) Study & Program Design and Evidence Generation: * Drives the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management * Leads clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses * Provides effective leadership support / oversight of evidence generation activities to assure patient safety and study delivery * Delivers value and access insights to inform medical strategy, expand market access and to address unmet patient need Creating Innovative Scientific and Technical Solutions: * Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology * Champions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * Bachelor's degree in a science related field * Extensive experience in Nephrology clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options * Extensive clinical trainin

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