In search of a physician career change opportunity or a new non-clinical career? An executive search firm is currently looking to fill the following position: Director Clinical Research – Immunology ( CA). Their client in La Jolla, CA, develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, metabolic disorders, inflammation disorders and pain.
As the Director Clinical Research – Immunology you are responsible for the development and execution of clinical programs for new chemical entities encompassing study design, protocol development and execution of clinical studies. Act as a liaison between company and clinical investigators. Develop credible relationships with opinion leaders, medical directors, and key regulatory officials in the relevant therapeutic area. Responsible either directly or in collaboration with assigned MD for medical monitoring/reporting and company safety officer activities. Evaluate adverse events (pre and post-marketing) for relationship to treatment. Assist Regulatory Affairs in determining requirement for any corrective actions or health authority reporting. Act as medical contact at company for the Food and Drug Administration and other worldwide health authorities concerning clinical/medical issues. Interpret, report and prepare oral and written results of product research in preparation for FDA submissions. Assist Regulatory Affairs in the development of drug/device regulatory strategies. Acts as company spokesperson regarding publication of clinical research findings and presentations to relevant FDA advisory committees. Create clinical education and support programs. Help explore and evaluate new product ideas to assist in identifying new marketing opportunities. Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance. Participate on cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc. Review medical literature and related new technologies. Responsible for assessment of external clinical research proposals involving company products relevant to company’s.
An advanced degree is required – MD , PhD, or PharmD degree preferred. Requires a minimum of 5 years of clinical and or research experience. A minimum of 2 years of industry experience, including clinical research and clinical study experience, is required. Work within the therapeutic area of immunology is desirable but not required. Approximately 15% – 20% domestic and international travel is required.
If you are interested in this position, please email a cover letter and your CV to info at prnresource.com, and we will provide them to the search firm looking to fill this position.
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