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Job #02931

About our client Our client is an acute care specialty pharma company based in San Diego. They specialize in a technology that provides sustained-release delivery of medications for post-surgical pain. Our client has two marketed products that are used by professionals in the healthcare industry. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Medical Director Parsippany, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in formulating overall clinical strategy 2) Work closely with Research and Business Development to strategically assess new internal and external product opportunities 3) Plan, implement and report Phase I-IV clinical studies to establish the safety, efficacy and commercial viability of new products 4) Participate (actively) in site selection and oversight to ensure Investigator compliance with study protocols, regulatory guidelines and company’s standard operating procedures 5) Serve as safety monitor (i.e. medical monitor) for ongoing studies 6) Interact with worldwide regulatory agencies as appropriate 7) Assist in preparing scientific papers and presentations 8) Work with Clinical Research, Clinical Operations and Medical Affairs staff and Regulatory Affairs in preparing project-related documents and regulatory submissions, including Investigator's brochures, annual reports, INDs and NDAs 9) Communicate and interact effectively with in-house personnel, clinical sites and outside contractors/CROs 10) Supervise Clinical Operations staff as well as a variety of consultants and CROs, including Site Management, Trial Monitoring, Data Management and Statistics 11) Work closely with Clinical Operations staff, Data Management, Regulatory Affairs, Project Management and CROs to ensure timely and effective designing, execution, safety monitoring, and reporting of Phase I-IV clinical studies 12) Provide medical leadership to the company's clinical programs 13) Participate in and have approval authority for clinical trial synopses and protocols 14) Perform medical monitoring functions for active protocols 15) Be involved with pharmacovigilance activities and review adverse event reports and PSUR documents and final study reports 16) Participate in creating, updating Investigator brochures and act as the approval authority for these brochures 17) Work as a member of a multidisciplinary Clinical Operations Team 18) Act as leader (as assigned) of one or more protocol execution teams 19) Play the lead role in working with Research and Business Development to strategically evaluate new product opportunities, both from the company's internal pipeline and external sources 20) Interact with the Commercial Team to provide input into phase 3b and phase 4 development activities 21) Take the lead for developing relationships with principle investigators as well as opinion leaders Requirements 1) MD (Ph. D. a plus)/BC/BE Internal Medicine or any other relevant field 2) 2+ years of clinical research experience in the biotech/pharmaceutical industry 3) Working knowledge of US and EMEA regulatory requirements 4) Excellent written and oral communication and presentation skills 5) Superb analytical and organizational skills 6) Ability to multi-task 7) Ability to work effectively in an entrepreneurial environment-based team