Avid Bioservices Inc (CDMO)

[biopharm]

Job Posting Update : Peregrine : 1 new ... now we finally start to get serious.... this tells me a serious partnership is coming soon and the money will be there soon to start branching out to more possibly PS Targeting indications....

All I have to say is "manages the clinical department budget..."

You mean Peregrine is going to have a budget soon?? : )

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Associate Director/Director, Regulatory Affairs Reg Affairs Tustin, CA 07-Oct-2014 (PST) Full Time

Clinical Data Manager Clinical Affairs Tustin, CA 21-Sep-2014 (PST) Full Time

Clinical Trial Liaison Clinical OPS Tustin, CA 18-Oct-2014 (PST) Full Time

Clinical Trial Manager/Senior Manager Clinical OPS Tustin, CA 11-Sep-2014 (PST) Full Time

Director/Sr. Director, Clinical Research Clinical Affairs Tustin, CA 21-Oct-2014 (PST) Full Time -New!

Laboratory Assistant Lab OPS Tustin, CA 28-Sep-2014 (PST) Full Time

Manager, Data Governance Information Technology Tustin, CA 18-Oct-2014 (PST) Full Time -New!

Manufacturing Associate - Downstream Manufacturing Tustin, CA 14-Sep-2014 (PST) Full Time

Manufacturing Associate/Senior Associate Manufacturing Tustin, CA 14-Sep-2014 (PST) Full Time

Research Associate, Process Sciences Process Sciences Tustin, CA 24-Sep-2014 (PST) Full Time

Sr. Manager, Clinical Quality Assurance Quality Tustin, CA 12-Oct-2014 (PST) Full Time

Sr. Research Scientist - Pharmacology Pre-Clinical Tustin, CA 05-Oct-2014 (PST) Full Time

http://peregrineinc.applicantpro.com/jobs/

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Director/Sr. Director, Clinical Research

Date: Posted 22-Aug-2014, Closing 21-Oct-2014 (PST)

Department: Clinical Affairs

Location: Tustin, CA

Employment Type: Full Time

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 research 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.

SUMMARY

The Director/Sr. Director, Clinical Research oversees the direction, planning, execution, and interpretation of clinical trials research and clinical operations. This role establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. The ideal candidate will have proven experience leading new and ongoing clinical research and clinical trials to ensure efficient and timely processing of confidentiality and clinical agreements. This key role interacts with investigational sites, clinical consultants, Contract Research Organizations and other vendors. We seek a dynamic experienced clinical team builder with strong abilities to select, develop, mentor and evaluate clinical personnel to ensure the successful and efficient operation of the department.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Oversees and manages clinical development including the efficient planning and execution of clinical trials within established budget and timelines assuring all activities are in compliance with appropriate regulation.
Optimizes tactical and clinical value through global site selection.
Oversees adherence to protocols and determines study completion.
Directs internal and external resources to ensure timely patient recruitment, trial site selection, trial plan optimization and execution of quality trials.
Leads, manages and directly supervises employees in the Clinical Affairs department.
Responsible for interviewing, hiring, training and performance evaluation of employees.
Plans, assigns and directs the work of employees.
Oversees the development and implementation of SOP's for clinical research including SOP's for clinical trials and related activities.
Manages the clinical department budget and ensures the overall operation is within budget and timelines are agreed to in annual strategic goal setting.
Communicates regular updates to the management team on progress against timelines and budgets in support of all clinical projects.
Must be available to travel up to 30% domestically and internationally.

QUALIFICATIONS

A Master's degree, MD or PhD in the life sciences is preferred. We require a minimum of 12 years of pharmaceutical industry experience to include significant clinical research leadership roles. Extensive background in direct management, development and supervision of a clinical operations team is required. Oncology clinical trials experience is highly desirable.

RELOCATION AVAILABLE

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.