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 Job #02530 Email this job to a friend
About our client
Our client is creating a fully integrated company in the biotechnology field focusing on the development and commercialization of a new technology. Their surfactant replacement therapies have prospective applications across the respiratory field. The company’s new technology is the base for its manufactured goods platform. Planning to use therapies to treat respiratory diseases, the company initially wants to target premature infants.
Position Location
Senior Director, Clinical Operations Pennsylvania
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Manage overall operations of worldwide clinical research (including project planning, budget and resource management)
2) Manage clinical operational plan and incorporate study and scientific plans
3) Develop and manage clinical budget and develop contingency plans for clinical trials
4) Supervise clinical trials staff
5) Formulate and develop operational objective and provide input into the department’s financial plan
6) Serve as the primary interface with clinical investigators and sites and to identify resources, vendors and systems to facilitate the efficient operation of the clinical program
7) Act as a cross functional liaison to ensure study plan aligns with business development strategies
Requirements
1) Ph. D or MD degree preferred
2) MS degree in a scientific area or RN/BSN
3) Minimum 10 years of experience in clinical development or clinical operations
4) 5+ years of managerial experience
5) Neonatology and pulmonology/critical care experience preferred
6) Knowledge of established clinical procedures, FDA and ICH requirements and expectations

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