Organization Overview

　　We pursue a combination of biochemical,molecular,and genetic approaches to define the checkpoints that regulate B cell development,antibody production,and B cell tolerance. A second area of interest is in dendritic cells. Our interests range from the earliest phases of the B cell pathway,including the commitment to becoming a B cell through the completion of maturation. Our ongoing work includes a focus on mechanisms of V(D)J recombination,somatic mutation,isotype switching,allelic exclusion,and tolerance.

　　Overview

　　The Laboratory of Molecular Immunology at the Rockefeller University conducts an active Phase 1 research program with the goal of understanding the human immune system’s response to viral infection. We are actively studying HIV and Hepatitis B and planning to bring additional anti-viral human monoclonal antibodies into the clinic over the next 5 years as our program continues to expand with the support of public and private funding. Our partners and collaborators in the US, EU, Africa and South America are a vital component of our leading edge global clinical research program.

　　Responsibilities

　　Regulatory 33%

　　Coordinate and maintain timely global regulatory submissions according to FDA, EMA and ICH regulations and guidelines

　　Solicit timely input from subject matter experts for global regulatory submissions

　　Assist with global regulatory submissions and ensure document quality and timeliness

　　Interact with service providers responsible for new regulatory submissions and responses to questions from global regulatory agencies in concert with agency timelines

　　Pharmacovigilance 33%

　　Submit reportable safety information following review by subject matter experts according to existing agreements and regulatory requirements

　　Maintain tracking systems for safety data reported from clinical trial sites and reported to partners, ethics committees and regulators

　　Create and maintain systems for distribution of safety and product related information to clinical trial sites as needed

　　Compliance 33%

　　Draft clinical/quality SOPs with appropriate input from subject matter experts

　　Finalize and maintain SOPs

　　Supervise training in clinical SOPs

　　Ensure staff compliance with SOPs on a regular basis

　　Qualifications

　　Education

　　BA required

　　Specialty training as applicable

　　Experience

　　Project management

　　Prior clinical trial and regulatory experience desired

　　Vendor management

　　Staff training

　　Quality Management Systems

　　SOP training

　　The Rockefeller University does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy, gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service or other non-merit factor. All qualified applicants will receive consideration for employment without regard to the characteristics listed above.

　　The salary of the finalist selected for this role will be set based on various factors, including but not limited to organizational budgets, qualifications, experience, education, licenses, specialty, and training. The hiring range provided represents The Rockefeller University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

　　Compensation Range: Min

　　USD $90,000.00/Yr.

　　Compensation Range: Max

　　USD $110,000.00/Yr.

　　Job Locations US-NY-New York

　　Category Science

　　Position Type Regular Full-Time