FierceBiotech and FiercePharma Jobs
Director Clinical Research - Immunology - The Cambridge Group Ltd.
Aug 01
Location: San Diego, CACategories: Pharmaceutical
Website: http://www.cambridgegroup.com
Position Description
Director Clinical Research – Immunology
Join this company that develops treatments that improve the health and lifestyles of people worldwide through research and development areas encompassing novel targets in neurologic disorders, metabolic disorders, inflammation disorders and pain. As the Director Clinical Research – Immunology, incumbent will be responsible for the development and execution of clinical programs for new chemical entities encompassing study design, protocol development and execution of clinical studies. You will also 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, and have responsibility either directly or in collaboration with assigned MD for medical monitoring/reporting and company safety officer activities. Responsibilities include: 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. Qualifications include: an advanced degree is required (MD , PhD, or PharmD degree); 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; work within the therapeutic area of immunology is desirable but not required; and approximately 15% – 20% domestic and international travel is required.
