Director, Clinical Affairs - In Vitro Diagnostics - Baltimore, MD

Description
Company with established, 510(k) approved device seeks clinical leadership to develop, execute, and monitor US registration studies for new In Vitro Diagnostic products including reagents.

Shall:

*** Design, execute, and manage clinical trial activities including site selection and monitoring, critical documentation collection and review, clinical status tracking,

*** Ensure documentation is prepared according to regulatory standards.

*** Select EDC (electronic data capture) system for trial sites.

*** Select sites and verify all participating labs are CAP or CLIA certified.

*** Develop training plans for study sites for sample preparation, analysis, and process controls.

*** Design, develop, plan, execute, and manage studies in support of product marketing activities.

Qualifications:

*** PhD, MD, or equivalent in scientific field.

*** Experience designing, planning, executing, and managing clinical studies for In Vitro Diagnostic products.

Highly visible director level position with a leader in the scientific community. Competitive salary plus bonus plan; company paid full family coverage medical, dental, prescription and vision; matched 401(k); and stock options are only parts of the complete employment package.

For details contact Branden F. Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:
1000024620_10007337@jobbank302.com

Please reference #36974130 when responding.
Years of Experience
10 + years
Location
Maryland
Low Salary
$150,000.00
High Salary
$240,000.00
Job Contact
Branden F. Lynch
Job Contact Phone
(609) 584-9000 ext 241
Job Contact Email
1000024620_10007337@jobbank302.com
Apply Online
http://dmc9.com/bfl/app.asp
City
Zip
Legal Notices
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Clinical Affairs Director Regulatory Affairs Product Registration Marketing Research Global Clinical Affairs R&D Research and Development Clinical Trials Clinical Studies PhD Clinical Research Medical Device Biotech Pharmaceutical Combination Product IVD In Vitro Diagnostic Product EDC Electronic Data Capture Late Phase III IV Studies Pharmacovigilance Post Market Safety Surveillance Reagent

DISCLAIMER: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.

If you submit an application or resume which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. To cancel receiving email communications, simply send an email from your address with the word "remove" in the subject line to pleaseremove@candseek4.com Or, visit the website at www.jobbankremove.com. If you have further concern regarding email received from us, call (609) 584-5499.