Sr Clinical Development Director, Neuroscience

GlaxoSmithKline ,
Brentford, Greater London
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Job Description

Neuroscience is an exciting emerging area of development within GSK, and a high area of unmet medical need. Programs in Neuroscience are a part of Specialty Medicine within our Clinical Sciences organization. Comprising a dynamic & collaborative community of clinical development physicians and scientists across Infectious Disease, Nephrology, Cardiovascular, Metabolic, and Rare Diseases, we are driving scientific innovation to deliver the next generation of transformational medicine for patients. We're seeking a Sr Clinical Development Director - Neuroscience for our evolving programs in Neuroscience. This is an exciting opportunity for a Clinical Development Lead to oversee the creation and execution of clinical development strategies for an emerging pipeline of Neuroscience medicines. You will be accountable for the creation of the clinical strategy for each therapeutic and oversee a clinical team accountable for trials to execute the strategy. In addition, you'll be the key internal expert for emerging Neuroscience opportunities for business development and in early phase development. You will be a specialist is required to be well versed in emerging trends and opportunities in all aspects of Neuroscience including Neurogenerative Disease and migraine disorders. This role offers you the opportunity to utilize advanced scientific and statistical principles and digital technology in collaboration with your peers, to help build GSK's emerging Neuroscience pipeline and to advance your career, both within Specialty and across Clinical Sciences. 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). Oversees selected clinical development projects for products/franchise of compounds Serves as clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development Interfaces with a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver the integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need Integrates 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 Continuously assesses when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit Anticipates problems and proactively seeks 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 ac

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