Sr. Director, Clinical Research - Biotech - Tucson Interested? Click Here to Apply! Not a fit? Click Here to Search all of CyberScientific Jobs Email this job to a friend - $1,000 | Apply - Click Here | Search other VP/Director Clinical Research jobs | Employer? Click Here Sr. Director, Clinical Research - Biotech - Tucson This position is open as of 9/13/2006! Skills: VP/Director Clinical Research, CNS Neurology, Biotech Pharmaceutical drug development, GCP Good Clinical Practices, regulatory compliance, clinical operations clinical trials Sr. Director, Clinical Research - Biotech - Tucson Location Tucson, AZ; Phoenix, AZ Salary $150,000 - $200,000 Education Medical Doctor Category Biotech Experience Required At least 10 Years Short Description Sr. Director, Clinical Research - Biotech - Tucson Recruiter David Wright Date Updated: 9/13/2006 Biotech Pharmaceutical drug development Jobs clinical operations clinical trials Jobs CNS Neurology Jobs GCP Good Clinical Practices Jobs regulatory compliance Jobs VP/Director Clinical Research Jobs Tucson Jobs AZ Jobs Sr. Director, Clinical Research - Biotech- Tucson CLIENT WILL RELOCATE FOR QUALIFIED CANDIDATES We are utilizing ground breaking medical technologies to develop products with the potential to revolutionize the treatment of stroke, and vascular disease.

We have a deep pipeline of development stage compounds.

Our innovative products hold significant advancements over current minimally invasive treatments, and are expected to provide improved patient outcomes, faster recovery times, shorter hospital stays and lower overall cost of care.

Responsibilities * Provides direction on clinical programs and assists senior management in developing Clinical functional objectives.

* Establishes clinical policies and interprets, executes, and recommends modifications.

* Coaches, mentors, and teaches others in the appropriate application of laws and standards in the areas of clinical trial design, compliance, and ethical conduct of trials.

* Develops/executes global clinical trial strategies, that are in compliance with all global regulations and consistent with our business and functional objectives.

* Ensures strategic alliances to ensure safe and successful clinical trial conduct.

* Responsible for development of realistic clinical department budgets, schedules, and performance standards and directing the function in accordance with these parameters.

* Ensures timely preparation of clinical study reports and clinical documents in support of regulatory submission * Interacts with equivalent and senior level management concerning significant clinical matters to obtain services to support clinical objectives.

* Represents the clinical function as liaison with external contacts.

* Conducts briefings and technical meetings for senior management and clinical investigators.

Facilitates the sharing of scientific and clinical data.

* Analyzes and presents data from external/internal sources and partners with other functions such as Regulatory Affairs to obtain regulatory product approvals.

* Provides direction for resolution of complex issues concerning the management of investigational site activities, safety, ethics, and physician relationships.

* Guides clinical employees in clinical trial management.

Allocates/re-allocates internal and external technical resources, as needed.

* Guides development of corporate-wide clinical standards for content and quality of clinical trial documentation.

* Drives policies, procedures, and processes that incorporate innovative trends and practices in the field of clinical research.

Develops and maintains Clinical functional infrastructure.

* Guides and prepares the organization to proactively comply with regulatory agency decisions and changes in regulations.

Qualifications/Competency Expectations * 15+ years of pharmaceutical/biotech industry experience, as well as supervisory capacity managing both clinical professionals and projects in a product development setting.

* Possess a thorough knowledge of modern study conduct practices both in the US and abroad.

* Extensive experience in all facets of clinical research, including study concept and protocol generation; CRO vendor identification and evaluation; contract generation and negotiation; independent management of studies and in collaboration with CROs, and in generating study reports and clinical trials documentation.

* Proven ability to write clear and concise scientific documents to be used as the basis for regulatory filings.

* Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.

Are you a fit for this position? Please Click Here to Apply! Not a fit for this position? Click Here to Search Other CyberScientific Jobs! Looking forward to receiving your resume through our website and going over the position in more detail with you. Clicking apply is the best way to apply, but you may also - email your resume in Word to: David.

Wright [at] CyberScientific [dot] com **Please do NOT change the email subject line in any way. You must keep the JobID: CC HotJobAp : DW-AZ-VPCR1 -- in the email subject line for your application to be considered.

*** Looking forward to receiving your resume! David Wright - Senior Recruiter - CyberScientific Is this job not quite a fit? Search hundreds of open positions to find the right one: Click Here to Search Other CyberScientific Jobs Earn a $1,000 referral fee - Know someone who is a GREAT fit for this position? Simply: Click Here to Refer a Friend If they get any job through us from your referral, we will pay you $1,000 after their first 90 days! Employers: Interested in our recruiting services? Employers - Click Here for More Info on Our Recruiting Services Best way to apply? Applying directly on our website by Clicking Here is the best way to ensure that your resume is seen by the hiring manager.

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