Job 08-005
Manager, Global Scientific Affairs
Summary & Scope of Position:
The major focus of Cerus Corporation is to develop medical device, biological, and pharmaceutical products. The company is currently focused in the area of Transfusion Medicine. Cerus is launching INTERCEPT Blood System for platelets and plasma in Europe, Middle East, and Asia, 2 of 3 products for improving the safety of transfusion. These products are expected to have a major impact on the way in which blood components are prepared in blood centers.
The incumbent will provide critical function in the introduction of these products in Europe, Middle East and Asia. The incumbent will perform in the following broad areas: provide a lead role in the development and execution of investigator sponsored in vitro studies, provide critical input into post-marketing Phase IV experience trials, capitalize upon synergies between platelets and plasma, leverage investigators as advocates for future speaker bureaus, and broaden publications.
Primary Responsibilities:
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Provide a lead role in the development, conduct, and reporting of investigator sponsored in-vitro studies to support the INTERCEPT Blood Systems in the market.
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Develop the scope and objectives of in vitro studies with investigators.
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Prepare study protocols.
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Perform monitoring function to ensure timely progress of the studies.
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Provide scientific expertise in data analysis.
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Work with investigators on final report and publication.
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Develop principal investigators as future advocates for INTERCEPT.
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Actively participate in the Phase IV core team meetings and play a key role in the decision making process for research direction and funding.
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Provide support to all Phase IIIb/IV studies for INTERCEPT platelet, plasma, and RBC.
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Develop and track budget and timelines of all in vitro studies.
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Lead publication committee.
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Develop annual abstract submission plan and coordinate with marketing team to develop congress symposium programs.
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Develop annual publication plan and the top ten publications.
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Author and assist in the writing of peer reviewed manuscripts.
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Provide scientific support to the Cerus Europe BV sales and marketing organization in the areas of virology, hematology, toxicology, and clinical trials.
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Provide assistance to deployment team to develop educational materials for customers.
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Develop relationships with key European and the rest of the world thought leaders in the area of transfusion medicine, infectious disease, and hematology.
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Provide expertise in product specifications, clinical studies, toxicology to physicians, transfusion committees, blood centers, target customers and Cerus Europe BV commercial organizations.
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Present scientific data and product/medical information to transfusing physicians, hematologists, oncologists, surgeons and other physician targets.
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Perform other related duties as required.
Qualifications/Requirements:
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Ph.D. or MS with equivalent experience.
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Strong scientific background in one of the following: Biology, hematology, transfusion medicine, or infectious disease.
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Strong background in blood bank operation highly desirable.
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Strong organizational and writing skills preferred.
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Experience with conducting regulatory submission quality studies.
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Communication and presentation skills with the ability to interface at all levels including management both internally and externally (encompass verbal, written, interpersonal, listening skills).
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Time management (timeliness, schedules, task prioritization).
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May require 20% or more time spent abroad.
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