美国西雅图弗莱德哈钦森癌症研究所博士后招聘

Post-Doctoral Research Fellow : Seattle, WA, United States

The Research Associate will be responsible for providing research and regulatory support to an investigator-initiated Phase I clinical trial of gene therapy for HIV+ patients. This position requires an MD, PhD or equivalent degree. Research or clinical training experience in virology, cell biology, hematology, gene or cell therapy is preferred. The position provides training in conduct and regulation of human subjects research.

The incumbent will oversee communications with the FDA and other federal and local regulatory agencies and committees, provide direct support to the study team in the preparation and submission of regulatory documentation and assist with trial coordination and monitoring. Research will include preclinical studies required for clinical translation of the therapy under Good Manufacturing Practice (GMP) conditions, as well as laboratory studies included in the trial as part of patient follow-up. Presentation of the study to diverse groups will be required, thus candidates with excellent communication skills will be given preference. The incumbent will work under the direction of the Principal Investigator and Sponsor within the Clinical Research Division.

- Provides proactive regulatory support throughout the lifecycle of the clinical trial
- Develops internal processes and standard operating procedures for cell manufacturing specific to the clinical trial
- Provides regulatory support as needed for clinical monitoring activities
- Develops and oversees laboratory testing as part of trial follow-up for enrolled patients
- Attendance and proactive participation in related project meetings, conferences, and publications

Experience and Abilities
- 3 – 5 years training or experience in a pharmaceutical, biotechnology, or academic clinical research setting
- Knowledge of regulations and guidelines that govern clinical research and manufacturing, including, but not limited to FDA, cGCP, cGMP regulations
- Good publication history
- Working with all levels of a research team
- Knowledge and Skills

- MD, PhD or equivalent professional degree
- Familiarity with gene or cell therapy preferred
- Strong verbal and written communication skills
- Ability to work collaboratively and build relationships across large organizations