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Job #02898

About our client Our client is a small start-up biotech company located in the Midwest. They have a promising compound for age-related macular degeneration. They offer strong bonuses and stock options to their entrepreneurial employees. Position Location Vice President of Clinical Operations Midwest Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage clinical leadership of all clinical programs 2) Drive growth of the company by moving research leads into development and development programs to approval 3) Establish the strategy and drug development plans (CDP) for relevant programs within the company 4) Influence the adoption of CDP in the company and facilitate cross-functional implementation across the organization 5) Develop effective clinical research plans and clinical sections of NDAs to the FDA as well as other health authorities 6) Ensure effective planning, directing and execution of clinical trials 7) Manage clinical investigators, sites and personnel involved in clinical activities 8) Ensure development and effective implementation of the highest quality clinical protocols, identification of appropriate clinical sites, preparation of final reports, and other key actions 9) Oversee (as a member of the senior management) the company-wide strategy and operations 10) Represent the company (as necessary) to internal and external groups 11) Function as an expert liaison between the company and leading academic specialists 12) Lead key regulatory and KOL interactions (as appropriate) 13) Identify high volume centers and introduce the company's product lines 14) Lead rigorous external review of the company's clinical pipeline 15) Plan and submit IRB approvals for clinical investigational activities 16) Provide transparent access to clinical program progress and potential internal or external issues (on an ongoing basis) 17) Provide leadership and communications to Direct Reports 18) Work with all levels of employees, executive management, Scientific Advisory Board, consultants, etc. to communicate the progress, technical risks and key issues of clinical programs 19) Interact with thought leaders in the academic medical community as well as domestic and international regulatory agencies 20) Perform all duties and tasks as required by the company’s policies and procedures Requirements 1) Master's degree, MD or Ph. D. in a scientific field (or a relevant discipline) and relevant industry experience 2) Minimum 3 years of experience in leading drug development (in the pharmaceutical or biotechnology industry) 3) Experience in early- and late-phase drug development, leading to marketing approval preferred 4) Familiarity with pre-IND, IND and NDA requirements associated with the development process 5) Experience in working with FDA, EMEA regulatory agencies and knowledge of their requirements 6) In-depth understanding of current trends in pharmaceutical science and ability to use that knowledge to improve the drug R&D process 7) Ability to communicate effectively with individuals and groups at various levels in the organization 8) Conscientious, enthusiastic team player with ability to work in a cross-functional team environment 9) Excellent interpersonal and communication (verbal and written) skills 10) Superb people management and leadership skills 11) Ability to effectively lead and motivate employees 12) Ability to build and maintain working relationships (inside and outside the department) 13) Ability to diagnose issues and problems, develop alternative solutions, take decisions and act with a sense of urgency 14) Ability to work under pressure as well as to plan and prioritize 15) Well-organized, detailed-oriented with ability to take initiatives 16) Strong focus on meeting the organizational objectives, proactively taking appropriate action, and seeking opportunities to improve the value delivered to the organization 17) Hard working and motivated to achieve creative as well as sound results 18) Ability to effectively influence decisions inside the organization and overcome obstacles 19) Ability to produce quality materials within tight timeframes and manage several projects simultaneously