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Associate Director, Clinical Development Job
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| Employer Name: BiotechCrossing |
SpiderID: 2267912 |
| Location: Blacksburg, Virginia |
Date Posted: 6/9/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5297290 |
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Job Description:
RESPONSIBILITIES Assist with development of the clinical and regulatory strategy and design of clinical development plans, clinical SOPs, and Phase I-III clinical trials Collaborate in the writing of clinical study protocols, case report forms, amendments, study manuals, investigator brochures, informed consents, and other study-related documents Participate in selection of and assist with oversight and management of outside contractors (CROs, central laboratories, independent contractors, etc.) and investigator sites, including negotiation of contracts Assist with development and management of clinical trial budgets Participate in investigator meetings to ensure training of investigators, study coordinators, CROs, and central laboratories with respect to clinical trial protocols and operational expectations Manage all operational aspects of Phase I-III clinical trials, including timely initiation, patient recruitment, and closeout of clinical studies Serve as project manager (track execution of projects, meet deadlines, negotiate and monitor budgets, assign and adjust resources, resolve problems, and alert senior management to changes in scope) for preclinical, regulatory, CMC, CMO, and CRO activities to ensure full alignment with the activities of the clinical development program and therapeutic development goals Monitor safety aspects of clinical trials and ensure that serious adverse events and other safety issues are reported to regulatory authorities in a timely manner Participate in review of data edits to ensure timeliness of clean data and data quality. Adequately manage all clinical trial data and effectively communicate such data to management as necessary. Provide senior management with timely updates on progress and changes in scope, schedule, and resources for clinical studies Contribute to review and/or preparation of clinical trial study reports, abstracts, presentations, manuscripts, and clinical sections of regulatory filings (INDs, PSURs, Annual Reports, Supplements, NDAs, BLAs, Expert Reports, etc.) EDUCATION AND EXPERIENCE Bachelors/Masters degree in a life sciences/allied health field. 5-10 years of clinical research/development experience in a pharmaceutical company, biotech company, or CRO Demonstrated ability to successfully manage operational aspects of Phase I-III clinical trials Knowledge of GCP/ICH guidelines and FDA regulations with respect to the drug development process Prior drug development project management experience required Prior experience as a Clinical Research Associate preferred, but not required.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.biotechcrossing.com
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