Job Title: Director, Clinical Affairs
Reports To: Vice President, Quality Assurance, Clinical & Regulatory Affairs
Position Summary:
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.
Essential Functions:
 Comply with the company’s 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