FierceBiotech and FiercePharma Jobs
Vice President & Chief Medical Officer - DOR BioPharma, Inc.
Nov 26
Location: Ewing, NJCategories: All Categories
Website: http://www.dorbiopharma.com
Position Description
POSITION SUMMARY:
This position is responsible for providing medical direction, management and review of clinical trials and product development. Specific tasks include development of a clinical development program plan for new drug candidates, clinical protocol development, medical monitoring of clinical trials and analysis of study data and preparation of trial reports. May also serve as a Development Project Leader and will interact with all departments within DOR to ensure the successful progress of projects and clinical trials. This position will also include providing input to marketing programs and representing DOR at scientific, clinical and business development meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Manage the development of the current clinical trials.
• Track and report all adverse events and other marketed drug data and be familiar with the FDA and ICH requirements.
• Design, develop and implement the most state-of-the art, cost-effective and sophisticated electronic data systems utilized in clinical trials and development.
• Provide novel ideas for clinical indications, secondary indications, niche markets, and initiate decisions over the priority of clinical projects.
ADDITIONAL DUTIES:
Not applicable.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
Requires a M.D. with US medical license and training
YEARS OF EXPERIENCE:
• At least 7 years of relevant industry experience required.
• Must also have successful experiences with:
o designing phase 1, 2, 3 and 4 clinical trials;
o interacting with FDA and other health authorities toward marketing approval;
o effectively managing safety surveillance programs, medical advisory boards, etc.; and
o building and overseeing medical affairs.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
None.
OTHER SKILLS AND ABILITIES:
• Demonstrated experience managing multiple projects simultaneously with aggressive timelines.
• Experience and demonstrated ability to manage at a high level of productivity with minimum infrastructure.
• Experience in outsourcing management.
