Our client is global leader in ophthalmic and vision care products, Our
client is one of Fortune Magazine’s 100 BEST COMPANIES TO WORK FOR. They
are leading the way in the Research and Development of the most complete
line of medical device and pharmaceutical products in the ophthalmic and
vision care industry
Assistant Director- Clinical Operations Retina
Location: Dallas/Ft. Worth Metroplex, TX.
This individual must have Retina experience.
Requirements:
Is responsible for the clinical development of drugs and related therapies
for the treatment of retina diseases, in particular AMD. This position
requires initiation, monitoring, completion and reporting of Phase I to
Phase III clinical studies to support the development of drug products. The
successful candidate will supervise a team dedicated to the conduct of high
quality clinical trials of retina drugs.
The position reports to the Director, Retina Products Development, Clinical
Science. The individual will conduct and supervise monitoring of clinical
trials of retina product's in several hundred patients at multiple sites in
the U.S. and Canada. The position requires significant supervisory
experience of clinical research scientists (CRSs) and contract research
organizations (CROs). Approximately 15-20% travel for this position.
Duties and Responsibilities include:
Develop functional unit plans for clinical development of candidate drugs.
Function as clinical study manager in assigned projects. Initiate, conduct,
supervise and co-monitor clinical studies. Validate clinical data and case
reports. Perform and supervise clinical quality audits at selected sites.
Write clinical protocols, case report forms, investigator brochures,
clinical study reports and clinical sections of INDs and NDAs. Coordinate
activities of other key clinical team contributors, including biostatistics,
product safety, microbiology, data management and information technology.
Supervise and train internal CRSs (CRA) and external CRO personnel. Select
investigators, IRBs, interface with CRO project managers and conduct
investigator meetings. Interact with clinical investigators, study
coordinators and medical monitors. Provide regular progress reports on the
conduct and status of studies to clinical and medical specialty management.
Qualifications:
An advanced degree (Ph.D. or Masters) in a biological or related scientific
discipline is required. Evidence of progressive accomplishment in positions
of leadership and three to seven years' experience in the conduct and
supervision of clinical studies (minimum 3 years in conduct of Phase III
studies) are essential.
For Consideration send CV and salary requirements to:
Lynn Smith
Marlin Scientific
Lead Recruiting Consultant / SCIP/ACS/AAPS
Main Office 972.423.2242
fax 972.424.0637
efax 801.881.3036
LynnS@themarlingroup.com
www.themarlingroup.com
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