To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03250

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. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for an Executive that wants to put their drive and initiative to work! Position Location Director of Clinical Research Tennessee Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct all aspects of Clinical Team management, development and operations 2) Ensure that Clinical staff is adequately trained and identify areas for professional development 3) Oversee strategic planning, execution and completion of domestic and international trials 4) Ensure the overall management of resources and the departmental budget 5) Devise processes that will support all clinical projects company wide and coordinate clinical operations including investigative site management and monitoring activities 6) Supervise all aspects of clinical development operations involved in Phases I-IV pharmaceuticals and pilot to pivotal for medical devices 7) Plan/manage data collection and analysis efforts, monitoring plans, site and patient recruitment plans, development of operational budgets as well as resource allocation forecasts 8) Oversee the activities of the Clinical Operations Group and their supporting staff including senior clinical managers, supervisors, field monitors, clinical compliance and others 9) Serve as a mentor and trainer to a larger multi-disciplinary department (hands-on approach) 10) Provide guidance and input into clinical trial management, progress reporting and risk mitigation planning 11) Ensure that clinical trials are implemented with quality, speed and value 12) Make major contribution to defining and evaluating strategies for clinical and regulatory development 13) Develop an organization capable of working virtually (i.e. making optimum use of internal/external resources and networks in order to create international clinical development teams) 14) Coordinate the reviewing, selection and management of vendors, contractors, contract monitors and other outsourcing options to support project goals when appropriate 15) Ensure that clinical trials are conducted and reported as per ICH GCPs, applicable regulations and relevant SOPs 16) Lead the development of clinical study protocols and reports (interim and final) 17) Maintain fiscal responsibility for large operational budgets 18) Ensure clinical SOPs’ implementation and compliance 19) Oversee annual reviewing and forecasting of department work load, staffing, resource allocation and budget Requirements 1) Advanced Science degree with strong preference of Ph. D. in Life Sciences 2) 15 years of industry experience in phases II-IV drug and/or pivotal Class III medical service clinical development which includes minimum 5 years of experience in clinical operations managing a large extended team (minimum of 25-50 department head count) 3) Minimum 5 years of experience with direct report responsibilities 4) Experience in drug and/or device safety and regulatory reporting requirements (domestic and EU) 5) Demonstrated experience in coordinating with regulatory, medical, statistics and data management functions to successfully complete clinical trials 6) International clinical trials experience 7) Medical/scientific writing experience in developing clinical research protocols and clinical submissions 8) Proven track record in successful completion of pivotal/Phase III clinical trials resulting in commercial approvals 9) Understanding of basic medical statistics in designing and analyzing clinical trials 10) Ability to lead effectively by creating shared vision and learning environment 11) Excellent organizational and project management skills 12) Proficiency in project planning and execution of all phases of clinical trial development (MS Project) 13) Proven ability to manage multi-faceted studies from inception through from implementation to completion 14) Proven ability for success in key management/leadership position including fiscal responsibility maintaining and accurately projecting and operating annual budgets 15) Willingness to travel internationally (up to 20%)