Job Description
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Title
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Director, Clinical Affairs
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This is the short description for the job opening. |
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Location
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Boulder, CO
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This is where the job is located |
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Job Description
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•Assume management responsibility for strategic planning, design, implementation and execution of clinical programs as well as interpretation of clinical study results, preparation of study summaries and reports for regulatory filings, presentations and publications for the Respiratory Division
•Demonstrate advanced, comprehensive knowledge of clinical and laboratory study design and principals
•Demonstrate advanced, comprehensive understanding of applicable Federal regulations, Good Clinical Practices and international standards
•Provide effective leadership/champion interests of the Clinical Affairs Department as a whole
•Establish direction for Clinical Affairs department, including clinical laboratories, clinical research, field research, and coordination of clinical studies.
•Develop SOPs and guidelines to assure internal files, site files and field data conform to Good Clinical Practice regulation and appropriate sections of 21 CFR
•Identify clinical training needs and develop training materials for in-house and clinical site use
•Assist in contractual negotiations for all clinical studies involving outside parties. Provide resources and oversight to any non-human clinical studies as necessary. Provide interface with FDA on clinical matters, including satisfying IDE requirements as needed
•Develop and review clinical study protocols and obtain IRB approvals
•Develop and manage departmental budgets
•Demonstrate advanced oral and written communication skills
Requirements
The candidate should have a Bachelor’s degree in a clinical discipline (B.S.N, etc.) and possess at least 10 years of work in the clinical environment and 5 years of work in the medical device industry in a management capacity.
Alternatively, an advanced degree with 5 years of related clinical experience and 3 years of medical device industry experience in management will be considered.
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Please describe the job you are offering. Do not include your company name or contact information here. Applicants respond by submitting their resumes. |
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Salary Range
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to $133.9K
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What salary range were you considering for this position? |
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First Question
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Years of experience with medical devices
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This is used to prioritize the candidates. You might ask years of experience with your technology. |
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Second Question
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Years of laboratory experience
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This is used to prioritize the candidates. You might ask years of experience in your industry. |
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Market Place
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North America
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The marketplace defines the visa requirements. Please let us know which market this job is in. |
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Employee Or Consultant
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Employee
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Are you looking for an employee or a consultant? |