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Senior Director of Clinical Operations 

Biotech / Science                      West Hollywood, CA. 90069  
Oncotherapeutics is a full service Contract Research Organization (CRO) dedicated to the therapeutic oncology area. With expertise in phase I-IV clinical trials and pharmacokinetic studies. Our comprehensive program encompasses laboratory research, protocol concept, design and development, clinical trial management, site monitoring, data management, biostatistics, safety review, clinical and database auditing, medical monitoring and medical writing.

Job Summary:
Senior Director of Clinical Operations must possess excellent management, interpersonal and communication skills needed to lead and manage full clinical operations of a growing and evolving oncology-specific CRO. This position requires a candidate with in-depth knowledge of all aspects of the clinical trials process who has demonstrated the ability to form new alliances. The candidate will oversee and direct all new and existing business development and will manage a three to five member staff of varying skill levels.

• 10+ Years Experience working with CRO
• At least 2 years Oncology clinical research experience
• Strong knowledge of FDA regulations and ICH guidelines
• Solid, hands-on experience with all aspects of Phase I through Phase III clinical trials with a good understanding of Phase 3 to Phase 4.
• Exceptional presentation and written skills, ability to write and propose projects for potential sponsors.
• Demonstrated success managing multiple projects simultaneously
• Strong attention to detail
• Excellent communication skills (oral and written) and interpersonal abilities required

Job Overview:
The Senior Director of Clinical Operations is responsible for the management of all clinical studies being conducted by Oncotherapeutics. The Sr. Director will be able to effectively plan, implement, monitor and provide monthly reports on the status of each study. The ideal candidate must have strong clinical operations experience and demonstrate a thorough understanding of cross functional clinical processes including data management, regulatory management, site recruiting, patient recruiting, communication with investigators, site monitoring and management, biostatistics and medical writing. A thorough understanding of FDA regulations, GCP regulations and ICH guidelines is required. This candidate will be able to manage and communicate the overall plan for a given project, including timelines, costs and key data issues. The Sr. Director must demonstrate strong business development skills, including the ability to create long-range development plans and execute short range plans within a team structure. This candidate will be asked to attend industry select seminars, and be available to speak as an authority on topics surrounding trends and forecasts in oncologic clinical trials. Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.

Specific responsibilities:
• Lead and manage all clinical trials for Oncotherapeutics
• Oversee and direct all new and existing business development
• Responsible for hiring and managing all in-house employees as well as regionally based CRAs and contractors
• Negotiate Master Service Agreements, Clinical Trial Agreements, and Change Orders
• Develop and negotiate CRO and clinical site budgets
• Plan and manage study timelines
• Assign and train project teams on new and amended clinical trials
• Responsible for the development and implementation of company SOPs
• Conduct study specific Project Update Meetings with sponsors, vendors and clinical sites
• Represent the company at major annual conferences including ASH and ASCO in business development endeavors
• Assist in the development of clinical trial materials including protocols, amendments, ICFs and CRFs
• Create study specific Monitoring Plans, Safety Plans and guidance documents as needed
• Plan and run Weekly Staff Meetings
• Manage various vendors for all projects that the CRO is involved with
• Support company goals, objectives, policies and procedures

This position does not include relocation. We prefer to look at candidates who are in the Greater Los Angeles region.

Please send your resume to:
Cheryl A. Cross, MPH

* Location: West Hollywood, CA 90069
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* Please, no phone calls about this job!
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