Peregrine Pharmaceuticals, on the list of Deloitte & Touche’s 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical trials management expertise and pharmaceutical industry experience to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA. In addition, we are conducting a Phase II breast cancer study with Bavituximab.
The Clinical Trial Manager/Senior Manager develops strategic clinical approaches for the overall clinical development of a biotechnology or pharmaceutical product, domestically and/or internationally, by performing the following duties personally or in collaboration with clinical team members:
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Protocol design and implementation
• Manage study start up activities
• Participation in site training
• Site management and visits
• Vendor selection and management (CRO, central lab, etc.)
• Ensure integrity of clinical data
• Ensure adherence to regulatory and company guidelines
• Evaluation of clinical data
• Assist with regulatory filings
• Necessary administrative activities as part of the project team
• Safety reporting
• Assurance of adherence to regulatory guidelines and SOP’s
A Bachelor's degree (BA or BS) in life sciences from a four-year college or university is required. At least 5+ years of pharmaceutical industry experience in the role of clinical trial manager responsible for clinical/regulatory monitoring is essential. Must have a background in multicenter clinical studies with appropriate knowledge of GCPs and regulations. Oncology therapeutic experience is preferred.
Primary management of at least one multicenter study and other Phase 1-3 studies using CROs is also required. Experience drafting or reviewing technical documents such as protocols, clinical study reports, clinical sections of IND/NDAs, and safety reports is needed. In addition, knowledge of clinical study guidelines including FDA, ICH and GCP is essential. Familiarity with the drug development process is required.
Occasional overnight travel by land and/or air may be required to attend meetings, out of state site visits, conferences, etc.
Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.
EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Peregrine Pharmaceuticals strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.