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Miles
Km80.5

Associate Director, Scientific Affairs

Cerus Corporation

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Location: Concord, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: ADSA Required Education: High school or equivalent

Description

Summary & Scope of Position:

The Assoc. Director of Scientific Affairs will lead Global Scientific Affairs activities and Research studies that support current business and allow the evaluation and development of novel IP.  This person will play a pivotal role in the support  of the INTERCEPT products globally by performing in the following broad areas: oversight and execution of post-marketing in vitro and clinical experience studies, working with the Cerus sales and marketing group as a scientific / technical liaison, managing investigators as advocates for future speaker bureaus, supporting the design and review of scientific protocols for in vitro studies, review of scientific content in regulatory documents  and  broadening INTERCEPT publications.  

Primary Responsibilities:

•   Provide scientific support to Global sales and marketing team in the areas of transfusion medicine, hematology, toxicology, and clinical trials.
•   Design and manage in vitro laboratory studies and Phase IV Post Marketing Experience Trials for Intercept Platelets, Fresh Frozen Plasma, and Red Cells.
?   Support scientific and clinical studies
?   Identify and evaluate investigators, define study end points, prepare study protocols
?   Work with investigators on data analysis
?   Work with investigators or independently on publications
?   Identify and pursue grants for outside funding
?   Coordinate studies with overall sales/marketing objectives
?   Develop advocates
?   Develop and track budget and timelines
•   Develop relationships with key international thought leaders in the area of transfusion medicine, infectious disease, and hematology.
•   Perform liaison role with Cerus Clinical and Regulatory departments for evaluation of post marketing study planning and results.
•   Initial country focus will include the US, Latin America and Asia Pacific.
•   Assist in the development of in-vitro studies to support the Intercept Blood Systems in the market.
•   Present scientific data and product/medical information to transfusing physicians, hematologists, oncologists, surgeons and other physician targets.
•   Perform other related duties as required.

Requirements

•   PhD or MD with a minimum of 7 years of related experience.
•   Strong scientific background in the areas of hematology, serology and hemostasis/coagulation and, transfusion medicine, desired. Laboratory expertise a strong plus.
•   Previous experience in either clinical or scientific affairs at a major biotech, medical device or pharmaceutical company a positive.
•   Strong writing skills.
•   Experience with clinical trials, and regulatory applications desirable.
•   Communication and presentation skills with the ability to interface at all levels including management, both internally and externally (encompass verbal, written, interpersonal, listening skills).
•   Experience and flexibility in foreign travel (~15%)
•   Ability to interface with sales and marketing organizations.  
•   Time management (timeliness, schedules, task prioritization).
•   Proficient in English.  Scientific and conversational Spanish highly desirable.  Additional languages a plus, especially Mandarin Chinese and Portuguese.

Ideally

•   Proven experience with Blood products and coagulation/hemostasis
•   Prior experience in customer interactions
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