CastleRock Technology

Vice President of Clinical Data Services

Do you have a minimum of eight years experience as a Director level
Biostatistician with the impetus, talent and drive to play a key, VP-titled
management role within a CRO?  If so, we'd like you to join our seven
person senior management team and mold, develop and manage our clinical
data science department.   We are a clinical research organization going to
war with cardiovascular disease - the number one cause of death worldwide.
 

We are a wholly owned subsidiary of a $25M organization, created as the
for-profit side of the house.  As a full service CRO, we bring new
cardiovascular medicines and devices to market, providing state of the art
scientific and clinical support to major pharmas, biotech companies and
manufacturers of medical devices.  At our SF Bay Area headquarters, we
design and conduct clinical research and multi-center studies for new and
existing medicines and devices in all clinical phases of drug development.
Since we can leverage the academic research and clinical databases of our
parent, we have a competitive edge in our work.  These databases hold
information on more than 26,000 cardiac surgery patients and 6,000
non-cardiac patients. With access to these proprietary databases, we can
support critical study design and protocol development decisions leading to
an accelerated clinical development program.

In this highly visible position, along side our CEO, you will:
Direct all statistical planning for Phase 1 to Phase IV clinical programs.
Work with clinical development teams to design and conduct clinical trials.
Coordinate the design and management of databases.
Develop the formal methodology for our statistical analyses and conduct
statistical programming, design and analysis.
Prepare regulatory submissions such as clinical study reports, integrated
summaries of safety and efficacy, and annual regulatory report.
Manage project timelines, budgets and allocate resources.
Represent us at client meetings and industry related activities.
You will have managerial oversight for four individuals growing to six.

Academically we ideally want  a PhD in statistics or biostatistics.  If you
have an MS degree, then your industry experience must make up for that.
On that score we are seeking no fewer than 8 years in a biotech and/or
pharmaceutical company.
Broad-based knowledge of clinical trials methodology, regulatory
requirements and statistical software.
Excellent analytical, problem solving, and computer skills.
Current or previous title as a Manager.

While we must have the technical skills above, there is more to this
position than science.  We want someone who, can work with our CEO and be
his scientific expert during new business presentations.  Thus you must be
comfortable meeting with clients and prospective clients at dinner, at
seminars, at investigator meetings, at tradeshows.  Someone with the
knowledge and business development skills to help sell our clinical data
services.  In these encounters you will be meeting with major pharmas,
biotech companies and other CROs.

As a newly created company we have a very fluid environment; now is a great
time to get your foot in the door.  Where large companies like a Quintiles
or a Genentech hire people to do one function forever, we are able to offer
a broader expanse of responsibilities and opportunities.

If hired for this position you would be considered an exempt employee.
Flex time will allow you to make your own hours and avoid commute traffic.
Salaries will range up to $150k.

Our researchers have distinguished themselves in the areas of perioperative
and cardiovascular medicine and we now are making a mark in such additional
therapeutic areas as Cardiopulmonary, CNS, Oncology, and Women's Health.
We are poised for significant growth and want to talk with someone who can
be a difference maker.

We cannot consider overseas candidates or sponsor h-1b visas.

Please send a resume to:

Jerry Bires
Sr. Consultant
CastleRock Technology, Inc.
415-289-3780, x224
jbires@crti.com