Spectrum Pharmaceuticals, Inc.
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Senior Manager Clinical Operations
at Spectrum Pharmaceuticals, Inc.
Summary: Designs, implements and monitors clinical studies of compounds designated for clinical development. Develops protocols and case report forms, which will provide adequate efficacy and safety information for Phases 1 to 3 of clinical trials.
- Interacts with data management personnel to plan data entry and analysis; recruits/screens/selects competent investigators; organizes investigators' meetings; assures that Good Clinical Practices (GCPs) are followed;
- Assures timely completion of studies; monitors data for safety and efficacy trends by reviewing clinical data; and writes clinical reports upon completion or termination of studies (in cooperation with statistical staff).
- Reviews requests for results of Investigational New Drugs (IND) studies, and provides input for pharmacokinetics and pre-clinical studies.
- Prepares clinical portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios.
- Plans clinical programs and develops a timetable, budget and resource analysis for clinical programs and personnel administration.
- Establishes and maintains relationships with alliance partners, external companies, investigators and opinion leaders to optimize performance on clinical trial activities.
- Prepares manuscripts for technical journals and makes presentations at scientific meetings
Skills, Education and Experience:
- Require a MD/PhD in a relevant scientific discipline
- A minimum of 5-8 years' experience in clinical research.-
- Must be available to work in the evenings and weekends, as required.
Position Location and/or Territory and Travel
- Position is located in Irvine, CA.
- Position will require up to_60_% travel (or) occasional local travel