Lead development studies to support the INTERCEPT Platelet and Plasma platforms with focus on registration studies with external collaborators.
- Assist in supervising laboratory team to support registration studies to meet corporate timelines.
- Interface with cross functional team leaders at Cerus.
- May act as Study Director 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 Biometrics 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, train and/or mentor research associates, assistant scientists, or scientists.
- Perform other related duties and support other projects as required.
- Ph.D. in a biology-related discipline preferred with a minimum of 2 years relevant experience or MS/MA in a biology-related discipline with a minimum of 8 years relevant experience; BA/BS required with a minimum of 11 years relevant experience.
- Excellent communication skills with the ability to interface at all levels including management (encompasses verbal, written, interpersonal, listening)
- Experience with platelet and RBC function and/or plasma coagulation desirable.
- Familiarity with GLP, GMP, and GCP regulations.
- Working knowledge of blood bank practices.
- Proficient in writing reports, regulatory submissions, and publications.
- Ability to work on complex problems in which analysis is required to determine appropriate course.
- Ability and presence to interface effectively at all levels; including customers, business partners, management, and employees globally.
- Highly organized with strong attention to detail and accuracy
- Flexible; ability to adapt to changing priorities.
- Solid experience with related computer software.
- Able to travel domestically
- Ability to work independently and as part of a cross-functional team.