Director, Clinical Operations at PMR Bio-Brain (North Carolina - Greensboro/Winston-Salem/High Point)

About PMR Bio-Brain:     compress
PMR Bio-Brain is an executive search firm dedicated to the pharmaceutical and biotech industries. Our focus includes hospital executives, hospital pharmacy, and allied health professionals.

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About the Opportunity/Requirements:     compress
My client is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. Our mission is to utilize our innovative technology to rapidly translate the functional modulation of human proteins into safe and effective medicines. We have a pipeline of small molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases including central nervous system disorders, cardiovascular disorders, type I/II diabetes, obesity, and cancer. We have built our product candidate portfolio through internal discovery. We are advancing our product candidates through in-house research and development efforts. In addition, we have strategic collaborations with leading pharmaceutical and biopharmaceutical companies that have contributed to our portfolio of product candidates. We believe the quality and breadth of our product candidate pipeline, platform technology, scientific team and strategic collaborations will enable us to become a fully integrated pharmaceutical company.
Myclient is excited to be opening a Phase I Clinical Research Unit, which is scheduled to open in December, 2008. My client is currently recruiting seasoned clinical research professionals who will be instrumental in building this new business unit from the ground up. Applicants need to be independent, proactive, and bring an entrepreneurial approach to their extensive experience in Phase I clinical trial management. Phase I Clinical Research Unit experience is highly preferred.

Requirements
1)Education: Master’s degree in an appropriate discipline
2)Professional experience: 8 to 15 years of clinical research experience, with preference given to candidates with experience in a Phase I Clinical Research Unit
3)Expert ability to apply ICH/GCP and other guidelines, and FDA and other relevant regulations
4)Highly developed interpersonal and communication skills (written and oral)
5)Strong leadership skills
1)Accountable for the management of the Clinical Operations Department within the Phase I Clinical Research Unit. Direct reports will include Clinical Research Coordinators, Clinical Research Coordinator Assistants, and Recruitment Coordinators.
2)Manages human resources including workforce planning and hiring activities, performance management and daily monitoring of productivity; facilitates knowledge development and transfer; and ensures the efficiency and mobilization of the team in order to achieve the expected results.
3)Provide strategic and tactical planning within Clinical Operations to achieve completion of projects on time and within budget.
4)Ensure Clinical Operations teams have clear goals, objectives and milestones consistent with corporate objectives.
5)Responsible for protocol review and feasibility assessment.
6)Responsible for project team assignments and training implementation.


 

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