Senior Clinical Scientist – Retina As the world leader in ophthalmic clinical trials, Ora provides a complete range of development services, including drug, drug delivery, medical devices, and preclinical. Over the past 30 years, Ora has earned 34 regulatory product approvals for our clients. Our validated, industry standard models and established methodologies are paving the way for future regulatory approvals, both in the US and around the world. This Retinal Senior Clinical Scientist will design, oversee and conduct clinical research to develop and validate novel visual function endpoints in retinal disease, including tests evaluating various visual psychophysical metrics and correlation to retinal structural changes. It is expected that the senior clinical scientist will have a PhD or MD (or equivalent experience) in the field of visual function. Using this knowledge, the scientist will: • Conduct literature searches, interpret scientific literature, and evaluate various technologies, prepare analyses, interpret, and summarize data, and evaluate study data from tables and listings • Design, evaluate, and refine the appropriate battery of tests to assess retinal disease severity/progression, the ability of a pharmaceutical/device agent to prevent or reverse such disease and to correlate retina structural changes with retinal visual function, • Assess the retinal drug discovery pipeline and available mechanisms by which therapeutics at a biochemical level modify the particular ocular disease. This Senior Clinical Scientist will be expected to provide project leadership and be fully responsible for all deliverables within assigned projects including: comprehensive development and execution of research development plans; ensure that all support functions are adequately resourced; setting and achieving research milestones; developing and maintaining realistic research budget forecasts; and, heading up communications and publications. PRIMARY RESPONSIBILITIES: • Adapts, develops, and optimizes novel visual psychophysical tests for evaluation of visual function in patients with retinal disease. • Design and conduct clinical studies to evaluate and optimize visual psychophysical tests and retinal structural imaging for tracking retinal disease progression/severity and determining efficacy of therapeutic agents. • Seeks out opportunities for new data analysis and scientific improvements. Recommends systems upgrades, new systems, and process improvements as necessary. • Develops and designs comprehensive, scientifically sound, innovative, and efficient research development plans that are consistent with the global R&D strategy. • Delivers research projects on time and on budget, and in compliance with all regulations and SOPs and is responsible for timely communication of project related critical issues/events to Senior Management. • Contributes towards business development opportunities to promote scientific collaborations and partnerships as required. • Provides scientific support for client presentations, due diligence activities, and strategic planning activities as requested. • Works collaboratively with project and cross-functional teams. Liaise with functional areas (e.g. therapeutic area heads, data management, CMC, business development) on initiating, planning, executing, and resourcing preclinical studies to drive and complete preclinical programs. • Assists in the development and implementation of comprehensive publication plans, ensures quality of content and format of publications in accord with applicable regulations, guidelines, and corporate SOPs. Personally writes abstracts, posters, manuscripts from retina R&D clinical trials, coordinates internal and external reviews, and collates reviewers’ comments. Manages review and revision processes for multiple, concurrent projects REQUIRED SKILLS AND ATTRIBUTES: • A minimum of 5+ years of strong scientific experience in the field of visual function. • PhD or MD (or equivalent experience). • Demonstrates excellent interpersonal skills, good oral and written communication skills, knowledge of clinical research protocols and IRBs, strong knowledge of computer programming. • Extensive hands-on experience and in-depth scientific knowledge of the retina, including differential disease diagnosis, imaging techniques and therapies. • Demonstrated success through publications, presentations and academic and pharmaceutical experience. • Demonstrated leadership skills for team building, facilitation, problem solving, conflict resolution and negotiation and quantitative analysis. • Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and scientifically while balancing short-term and long-term company objectives. • Ability to work effectively across multiple functions, at all levels of management; lead multidisciplinary project teams and maintain project schedules on multiple programs.. • Ability to work well in a team environment, with the ability to work independently. • Strong external network and publication track record. • Working knowledge of AMA writing style sheet, ICMJE requirements, good publication practices (GPP2), FDA and ICH guidelines, and GLP compliance. Please e-mail cover letter and CV to: jpocklington@oraclinical Mailing Address: J. Pocklington Human Resources 300 Brickstone Square 3rd Floor Andover, MA 01810 Re: Senior Clinical Scientist – Retina jpocklington@oraclinical Fax: +(1)978-689-0020 Website: oraclinical
Posted on: Wed, 24 Jul 2013 10:18:06 +0000
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