Medical Director
A pharmaceutical company
located in Connecticut is seeking a Medical director
to plan, design and direct assigned clinical research
programs. Manage clinical portions of NDA submissions.
Participate in the development of long-range plans and
budgets for new products and new indications for existing
products that have been determined to satisfy a medical
need and/or offer a commercial potential. Work within
a clinical research group which operates in compliance
with Good Clinical Practices and develop relevant formal
training programs. Participate in new product acquisitions.
Candidate may function as the clinical leader on one
or more product team. May interact with marketing to
plan strategies for product life cycle and for clinical
research to support these strategies. Promotional and
other marketing materials review.
PRINCIPAL ACTIVITIES
Plan, design and direct Phase 2 & 3 clinical development
programs and serve as Project Core Team Leader or Member.
Function as clinical leader and medical monitor on
one or more clinical study teams including managing
clinical research scientists and CRO's and other responsibilities
attended thereto.
Ensure that all studies are designed and conducted
according to GCP's and internal SOP's.
Represents company at FDA as needed and with key opinion
leaders in the field.
Evaluate and recommend clinical development plans for
new clinical candidates that come forward through internal
discovery or as in licensed opportunities.
Interact effectively with all disciplines including
regulatory affairs, bio-statistics, clinical operations,
discovery research and marketing.
REQUIRED EXPERIENCE AND EDUCATION
Requires a minimum of a medical degree and specialty
certification preferred with a minimum of 5 years experience
in the pharmaceutical industry. A strong foundation
in clinical trial design, clinical data analysis, bio-statistics
and adverse event and safety reporting is required.
Some managerial experience/training would be advantageous.
Good communication and writing skills are required.
A thorough knowledge of FDA regulations and GCP is required.
Apply
Now!
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