Director, Clinical Affairs 

         
Job Description:
Provides direction and guidance in accordance with Good Clinical Practices employees in clinical trial research for new and existing medical devices and procedures for the treatment of diseases; makes decisions that translate programs established by senior leadership and translates into operational plans and schedules; manages the approval, direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Assists in filing of applications supporting regulatory approvals for sales worldwide. Reports To:   Vice President, Quality Assurance, Clinical & Regulatory Affairs

Responsibilities:
  ·         Comply with this quality system requirements as well as any applicable regulatory requirements
·          Recruit, train exempt and non-exempt specialist personnel to develop Clinical Affairs department staff
·         Forecast future departmental or group needs including human and material resources and capital expenditures
·         Determine and establish organizational structure
·         Coach and direct the Clinical Research team on operational principles and procedures.
·         Evaluate performance and assist in career development planning for subordinates.
·         Identify readiness for promotion through annual performance appraisals
·         Develop and /or identify new work processes and the improved utilization of human and material resources within the Clinical Affairs department
·         Create immediate- to long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions deadlines established by top management
·         Work with R&D to determine pre-clinical and clinical feasibility of new products.
·         Work with Marketing to choose investigators and clinical sites, prepare investigators meetings and training
·         Develop calculate a budget for Clinical department to meet organizational goals. Ensure that overall budget schedules are set realistically and attained
·         Participate in decision-making concerning CA department goals
·         Lead Clinical Affairs departments by developing, communicating, and building consensus for goals and programs that support division and company objectives
·         Mediate among multiple individuals or departments to resolve conflicts or achieve consensus
·         Oversee proper collection of data and the development and maintenance of computerized data collection system. Manage ongoing analysis and synthesis of collected data. Analyze data and prepare documentation for submission to obtain clearance/approval for legal market distribution of medical devices
·         Manage the preparation of technical and scientific publications
·         Investigate and solve problems that impact work processes and personnel in multiple departments
·         Attend relevant scientific and medical meetings
·         Maintain up-to-date knowledge of global medical device regulations
·         Participate in industry task groups and manage external consultants as needed
·         May act as consultant/liaison with other corporations when working under licensing agreements
·         Represent the Company as prime internal contact on clinical contracts or operations
·         Conduct briefings and technical meetings for top management and customer representatives
·         Interact with equivalent level intra- and inter-organizational management concerning matters of significance to the company
·         Monitor progress of department toward divisional and company goals
·         Monitor all costs associated with Clinical Affairs
·         Monitor industry trends and external environment in areas relevant to Clinical Affairs
·         Interpret, and execute policies in a major segment of the company. Recommend modifications to company policies. Monitor compliance with policies and procedures
·         Travel:  50%

 
Education and/or Experience:   
 
§    Must have extensive Cath Lab/Coronary experience
§    BS/BS degree in Life Sciences plus 8 years of related experience, or equivalent combination of education and experience
§    Prior experience as leader of clinical trials
§    Prior people management and project management experience required