Associate Director, Hematology
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.