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Job #02657

About our client Our client is a young venture-backed biopharmaceutical company dedicated to the discovery of novel therapies for the treatment and prevention of blindness and other ophthalmic diseases. 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 someone that wants to put their drive and initiative to work! Position Location Vice President of Clinical Affairs Northwest, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure establishment of the conditions essential for determining safety, efficacy, medical usefulness and marketability of drug candidates 2) Implement clinical trials and interpret the results of Phase I and II investigations in preparing and presenting new drug applications to FDA 3) Guarantee clinical evaluation of potential drug candidates for licensing, partnering or acquisition 4) Handle the clinical leadership of all clinical programs 5) Ensure growth by moving research leads into development along with developing programs for approval 6) Establish strategy and drug development plans (CDP) for relevant programs within the company 7) Influence CDP adoption within the company and facilitate cross-functional implementation across the organization 8) Develop effective clinical research plans and clinical sections of New Drug Applications (NDAs) to FDA and other health authorities 9) Handle effective planning, directing and execution of clinical trials 10) Develop and implement the highest quality clinical protocols 11) Identify appropriate clinical sites along with preparing final reports and performing other key actions 12) Manage clinical investigators, sites and personnel involved in clinical activities 13) Act as a member of the Senior Management Team, handling company-wide strategy and operations 14) Represent the company (as necessary) to internal and external groups 15) Lead key regulatory and KOL interactions (as appropriate) 16) Liaise (expertly) between the company and leading academic specialists 17) Lead the rigorous external review of the company’s clinical pipeline 18) Identify high-volume centers and introduce the company’s product lines 19) Provide transparent access to clinical program progress and potential internal or external issues on an ongoing basis 20) Plan and submit IRB approvals for clinical investigational activities 21) Provide outstanding people leadership and communications to Direct Reports 22) Work with all levels of employees, including executive management and the Board of Directors, etc. and other audiences to communicate the progress, technical risks and key issues of the company’s clinical programs 23) Operate on the front line with thought leaders in the academic medical community, as well as domestic and international regulatory agencies 24) Perform all duties and tasks (as required) Requirements 1) MD and/or Ph. D. in a scientific discipline or equivalent with a strong relevant industry experience 2) Minimum 10 years of experience in successfully leading drug development efforts within the pharmaceutical or biotechnology industry 3) Experience in ophthalmology and CNS a plus 4) Understanding of early- and late-phase drug development, leading to marketing approval preferred 5) Familiarity with pre-IND, IND and NDA requirements associated with the development process, including strong experience with FDA, EMEA regulatory agencies and requirements 6) Superb speaking and persuasive ability at appropriate FDA and international regulatory meetings 7) Willingness to travel – up to 25% (including overseas travel)