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About PMR Bio-Brain:
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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.
Click here to go to the PMR Bio-Brain website.
For details about PMR Bio-Brain, click here.
About the Opportunity/Requirements:
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My client is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. 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. 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.
1.Manage all aspects of Quality Control, Quality Assurance of clinical research activities within the Phase I Clinical Research Unit. 2.Maintain Standard Operating Procedures that comply with all applicable regulations and guidelines as required 3.Ensure that all procedures, policies and systems stay current per applicable guidelines and regulations 4.Provide guidance and assessment of regulatory and GCP compliance on all Phase I Clinical Research Unit activities through internal audits, including corrective action planning, debriefing with CRU staff, and ongoing informal input 5.Establish and maintain training plans for each group of staff in the Clinical Research Unit 6.Interact with technical departments, customers, suppliers and regulatory agencies (i.e. FDA and DEA) in the review of issues and data
7.Prepare for and support Clinical Research Unit staff during Sponsor, Regulatory, IRB or other audits and inspections, and manage preparation of corrective action plans, 8.Manage correspondence with FDA and other regulatory authorities as needed 9.Actively participate as a member of the senior management team
1.Masters or Doctoral level academic qualification in Life Sciences
2.Minimum 7-10 years of relevant industry experience (Clinical Trial Monitor, Clinical Compliance Specialist, etc.) through positions of increasing responsibility in clinical research management, with a demonstrated interest in early phase trials. Experience in a Phase I Clinical Research Unit is preferred but not required
3.Extensive knowledge of and experience with ICH-GCP and other guidelines, and FDA and other relevant regulations and inspections
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