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Job #02835

About our client Our client is a leading medical device company specialized in ophthalmology and eye care products. They have over 13,000 employees globally and a reputation as a leading innovator in the field. With operations in 36 countries and a 150-year track record of success, this is a great situation for a candidate that is pursuing a challenging opportunity with a world-class employer. Position Location Director of Clinical and Scientific Affairs New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the development of products in the Rx, OTC, generics and nutraceutical categories 2) Lead a group of scientists (MDs and ODs) responsible for clinical trial designing and scientific evaluations during the conduct of trials 3) Work with scientists to monitor safety, eligibility, enrollment and data consistency as well as analysis of results 4) Lead product clinical development programs and ensure that they are of high quality as well as lead to timely and cost-effective regulatory approval 5) Work with the Pharmaceutical Global Clinical Development Matrixed Team to manage operations, statistics, data management and medical writing 6) Lead the Pharmaceutical Global Clinical Development Matrixed Team in the planning and executions of clinical trials 7) Collaborate and take a clinical leadership role within cross-functional teams, including project managers, pre-clinical, regulatory, clinical trial materials, etc. 8) Oversee clinical aspects of clinical study reports and responses to regulatory authorities 9) Contribute to abstract/manuscript/presentation writing or review for scientific meetings and internal management reviews 10) Maintain responsibility for clinical input into business development due diligences 11) Provide medical expertise and medical evaluation of questions regarding ophthalmology clinical practice 12) Develop/maintain relationships with external experts who might be needed to support clinical development programs 13) Provide scientific and clinical research expertise in the development of overall strategy of the pharmaceutical business and more specific product clinical development plans 14) Perform management functions as goal setting, individual development plans and performance evaluations of staff 15) Identify training needs of staff and implement training plan 16) Evaluate and contribute proactively to process improvement Requirements 1) MD from an accredited US or foreign medical school 2) 5+ years of experience in post-medical training, including clinical practice and industry experience in the planning, execution and reporting of clinical trials 3) Experience in ophthalmology 4) In-depth understanding of GCP, ICH and regulatory compliance 5) Knowledge of scientific methods, research design and medical practices and procedures in ophthalmology 6) Ability to work in a matrixed and cross-functional environment 7) Demonstrated ability to work independently, take the initiative along with a strong work ethic 8) Superb leadership and motivational skills 9) Excellent planning and organizational skills 10) Ability to influence internal and external stakeholders 11) Excellent interpersonal skills 12) Exceptional presentation and communication (oral and written) skills 13) Willingness to travel