Late Stage Clinical Development Physicians, Hepatology & GI
Site Name: UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Jun 21 2021 Are you looking for an opportunity where you can lead & contribute to the clinical development of transformational medicines for patients with GI & liver disease? Key responsibilities include Leading or 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 of 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 patients in the shortest possible timeframe Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP Supervision of ongoing clinical studies including prospective phase 2 trials, as well as phase 3 trials to support regulatory approvals globally. 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 Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for studies in development Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, Clinical Research Organizations, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile. Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MD or PhD Background in the scientific/pharmaceutical industry in pharmaceutical research 10+ years' experience in compliance, quality assurance and risk management areas, including root cause analysis Experience with FDA regulatory guidelines Experience with medical affairs activities including scientific engagement and promotional interactions Preferred Qualifications: Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance Exciting opportunities exist at our key R&D locations including Upper Providence, Waltham & San Francisco in the US, and London & Stevenage in the UK. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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