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Job #03287

About our client Our client is a rapidly growing medical device company headquartered in Colorado. The organization has an experienced management team, financial stability, exciting new products and one of the lowest employee turnover rates in the industry. This is an excellent time to join a firm that has both a lengthy history of success and a highly entrepreneurial culture known for rewarding people that thrive on new challenges. Position Location Director of Clinical Affairs Colorado Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop (with minimum direction) objectives, plans and protocols for clinical trials to achieve end results that support business strategies and goals 2) Oversee the conduct, coordination and management of clinical trials, clinical and national validation studies, post-marketing surveillance and hemo-vigilance studies 3) Assist in managing regulatory aspects of business by applying knowledge of regulatory requirements to areas of expertise such as international medical device regulations and standards, product reimbursement, liability and standards 4) Perform tasks for and lead all clinical trials 5) Provide clinical and limited regulatory advice to the Executive Team when required 6) Serve as an active member of the Executive Management Team, participating in all major strategic, tactical decisions and initiatives 7) Review proposals for clinical studies to ensure that they meet regulatory requirements, corporate objectives and company SOPs 8) Make recommendations to the Executive Management Team concerning whether proposal should be approved or not 9) Lead activities relating to negotiating CROs and Investigator agreements as well as clinical site selection 10) Organize and manage external groups participating in clinical trials including CROs, principal Investigator groups and data safety monitoring boards 11) Work with the scientific and marketing functions to develop designing of pre-clinical and clinical studies of new products and protocols to support product claims as well as regulatory submissions 12) Ensure proper planning, coordinating, monitoring and reporting on clinical studies conducted for the business 13) Identify appropriate resource requirement and their qualifications 14) Ensure adherence to protocols and company general policies regarding clinical studies 15) Establish study/trial priorities 16) Maintain state-of-the-art knowledge of the requirements for proper conduct of clinical studies/trials and the requirements of both regulatory and internal for international and domestic applications 17) Update departmental procedures as they relate to clinical trials, etc. based on any changes in regulatory requirements or company policies 18) Prepare reports/documentation for regulatory submissions derived from studies managed 19) Review study reports to determine that study/trial objectives are met and that the results are valid from a clinical perspective 20) Keep the Executive Management Team informed as to the results as well as any observations that may be of clinical or product performance importance 21) Maintain broad-based knowledge and understanding of regulatory requirements 22) Identify areas where the business can improve and establish operating policies with direction Requirements 1) Bachelor's degree in Nursing/Biological Sciences or in a related scientific discipline or equivalent 2) Advanced degree such as in Medicine preferred 3) Minimum 10 years of experience in conducting clinical trials in the medical device field 4) Global clinical trial management experience (EMEA) 5) Previous employment with small and large companies (preferred) 6) Experience in managing staff (direct headcount) and budgeting 7) Extensive experience in managing all phases of multi-center clinical trials –either medical device or drugs 8) International clinical trial experience 9) Industry experience in representing a company during early collaboration meetings with the regulatory authorities in Europe and/or the FDA staff 10) Experience in conferring with regulatory authorities regarding pending and proposed submissions 11) In-depth understanding of clinical trial reporting requirements 12) Thorough knowledge of the physiology and clinical practice of the relevant therapies 13) Knowledge of medical statistics and experimental designing 14) Broad knowledge of clinical methods, both laboratory and therapy delivery related 15) Knowledge of clinical study (GCP) and working knowledge of regulatory requirements 16) In-depth technical knowledge of European and international medical device regulations, standards, policies and guidance documents 17) Working knowledge of and ability to prepare regulatory documentation 18) Excellent organizational, communication (written and oral), strategic planning, cross-functional team skills 19) Superb leadership, management, interpersonal, writing and presentation skills 20) Proven ability to establish working relationships with all levels of Clinical/Technical/Marketing staff, both in a corporate, clinical and academic setting 21) Self-directed with ability to work independently 22) Demonstrated positive and proactive approach to identifying and defining problems as well as the developing and implementing solutions 23) Self-motivated in constructive and relentless pursuit of solutions as well as ability to motivate others to do the same 24) High level of initiative as well as willingness to take ownership and accept responsibility for actions and decisions 25) Ability to represent the business to both internal and external contacts 26) Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence 27) Highly adaptive individual with ability to coordinate and manage clinical trial activities on a global basis 28) Willingness to travel internationally (up to 30%)