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Job #03175

About our client Our client is a biotech company. They are a leader in the innovation and development of DHA omega-3 products which promote health and ensure wellness through every stage of life. Their products are used in foods, beverages, infant formula and supplements. Other products include an omega-6 fatty acid produced from fungus. Position Location Director, Medical Research Columbia, Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop (with the Executive Director of Clinical Research) a comprehensive pre-clinical and clinical research strategy covering near and long-term actions for development of DHA products consistent with marketing needs 2) Handle design and implementation of preclinical and clinical studies conducted under IND regulations and/or for support for NDA submissions (as needed) 3) Present aspects of the medical clinical research program to the Research Management Committee – Clinical 4) Develop written reports and make oral presentations 5) Work with Discovery Team to evaluate potential new or under-explored benefits of DHA 6) Develop and maintain plans for staffing and budget for Medical Research in consultation with the Executive Director of Clinical Research 7) Support the research program based upon a pre-determined strategy of what capabilities the company must have in–house and what may reasonably be outsourced 8) Build and maintain the Medical Research staff and assist with training 9) Maintain Clinical Research as a Good Clinical Practice operation with active, up to date, SOPs and training of staff 10) Provide medical review, input and oversight to development of protocols, Investigator brochures, regulatory filings, study summaries/ reports and manuscripts for publication 11) Provide critical medical review and analysis of Investigator-initiated protocols 12) Seek and work with thought leaders and most renowned clinical experts in fields of interest to the company to obtain advice and guidance on clinical research plans and to gain insight into FDA review requirements 13) Oversee Investigator network to be involved in future company-sponsored trials 14) Ensure successful and timely completion as well as regular reporting to management of progress for company-sponsored trials 15) Review, assess and report to management/business units or regulatory agencies (as appropriate) any adverse events reported to company 16) Work with Regulatory Affairs to develop appropriate SOPs to support the business 17) Provide adequate support, documentation, oversight and monitoring of investigator-initiated trials (as needed) 18) Establish relationships with key investigators in evaluating benefits of DHA outside of company's core application areas 19) Support new technology and business development through evaluation and due diligence relating to the medical benefits of new, non-DHA products which may be acquired or licensed 20) Facilitate good communication and coordination between Clinical Research, Sales & Marketing, Regulatory Affairs, Operations and Quality Assurance 21) Maintain medical and scientific skills by attending educational courses (as appropriate) 22) Ensure that all reports maintain skills appropriate to their jobs 23) Participate in academic and administrative organizations (as appropriate) for the current needs of the company and its clinical research program 24) Keep abreast of scientific literature relating to the company’s current and future products 25) Perform other duties as assigned by management 26) Oversee and direct the activities of others on the Medical Research Team, such as clinical project managers and clinical research scientists 27) Delegate project tasks as well as establish goals and timelines for team members 28) Lead and direct the work of other Medical Research staff on projects 29) Manage the performance and development of Medical Research staff and any outside consultants or contract service providers who may be involved in medical/clinical research 30) Guide team members to write manuscripts, reports or abstracts for publication Requirements 1) MD/MD, Ph. D. with minimum 5 years of experience in clinical research leadership roles 2) Board certification and a US license a plus 3) Successful track record in clinical research including experience in pharmaceutical product development as well as successful FDA negotiation for new Rx product labeling and release 4) Nutritional products experience 5) Experience in products in pediatrics, neurology, nutrition or cardiology preferred 6) Experience in performing clinical research in a smaller company environment a plus