Summary & Scope of Position:
Lead development studies to support the INTERCEPT Platelet and Plasma platforms with focus on registration studies with external collaborators. Be a technical expert and key member of the Development team in the areas of plasma.
Manage laboratory team to support registration studies to meet corporate timelines.
Interface with cross functional team leaders at Cerus.
May act as Study Director or Principal Investigator for internal or external Cerus registration studies.
Reduce and analyze highly complex data and present it to maximize clarity and impact.
Serve as a technical expert on project teams, including contribution of ideas, development and execution of plans, and timely reporting of the results.
Serve as technical expert on external collaborations and studies; including meeting with customers and other external parties as a representative of the company in area of expertise.
Work cross functionally with Clinical, Regulatory, Quality and Biostatistics departments.
Write protocols and study reports.
Maintain leading edge knowledge in primary field of expertise.
Maintain high level of professional expertise through familiarity with scientific literature and attendance at scientific meetings.
Write and submit abstracts to national and international conferences.
Present internally and at scientific conferences and contribute to scientific publications.
Support regulatory submissions to global health authorities.
Supervise, manage, and/or provide guidance to other personnel.
Train and mentor research associates, assistant scientists or scientists.
Identify patentable inventions.
Perform other related duties and support other projects as required.
Ph.D., with a minimum of 7 years relevant experience or Master's degree in a scientific discipline with a minimum of 10 years of experience.
Excellent communication skills with the ability to interface at all levels including management (encompasses verbal, written, interpersonal, listening)
Working knowledge of blood bank practices.
Familiarity with GLP/GMP regulations & record keeping.
Ability and presence to interface effectively at all levels; including customers, business partners, management and employees globally.
Ability to work on complex problems in which analysis is required to determine appropriate course.
Proficient in writing reports, regulatory submissions and publications.
Solid experience with related computer software.