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Job #03361

About our client Our client is the biotech division of a world-leading medical device company that has developed a reputation for successfully bringing complex products to the market in a variety of therapeutic areas. The company has strong financials, an experienced management team and a loyal customer base. Position Location Director of Clinical Research Arizona Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee strategic planning, execution and completion of domestic and international trials 2) Supervise all aspects of Clinical Team management, development and operations 3) Ensure that Clinical staff is adequately trained and identify areas for professional development 4) Implement processes that will support all clinical projects company-wide and coordinate clinical operations 5) Serve as a mentor and trainer to a larger multi-disciplinary department 6) Provide guidance and input into clinical trial management, progress reporting and risk mitigation planning 7) Ensure that clinical trials are implemented with quality, speed and value 8) Make major contributions to defining and evaluating strategies for clinical and regulatory development 9) Coordinate the reviewing, selection and management of vendors, contractors, contract monitors and other outsourcing options to support project goals when appropriate 10) Ensure that clinical trials are conducted and reported as per ICH guidelines, GCPs, applicable regulations and relevant SOPs 11) Lead the development of clinical study protocols and reports (interim and final) 12) Oversee annual reviewing and forecasting of department workload, staffing, resource allocation and budget 13) Ensure the implementation and compliance of clinical SOPs 14) Maintain fiscal responsibility for large operational budgets Requirements 1) Advanced scientific degree (Ph. D. in Life Sciences preferred) 2) 6+ years of industry experience in drug and/or medical service clinical development which includes minimum 5 years of experience in clinical operations managing a team 3) Minimum 5 years of experience with direct report responsibilities 4) International clinical trials experience 5) Experience in drug and/or device safety and regulatory reporting requirements 6) Demonstrated experience in coordinating with regulatory, medical, statistics and data management functions to successfully complete clinical trials 7) Medical/scientific writing experience in developing clinical research protocols and clinical submissions 8) Experience in managing overseas staff in India 9) Proven track record in successful completion of clinical trials resulting in commercial approvals 10) Knowledge of basic medical statistics in designing and analyzing clinical trials 11) Excellent organizational and project management skills 12) Proficiency in project planning and execution of all phases of clinical trial development 13) Willingness to travel primarily to Asian countries (up to 50%)