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. We are looking for a Assistant Director, University Clinical Research Program Regulatory and Compliance to assist with this program.

Responsibilities

Regulatory 34%

• 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
• Compile content for global regulatory submissions and ensure document quality and timeliness
• Interact with service providers responsible for new regulatory submissions and response to questions from global regulatory agencies in concert with agency timelines

Pharmacovigilance 33 %

• Submit reportable satefy 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
• Insure staff compliance with SOPs on an ongoing basis

Qualifications

Education

• BA required; Masters’ or equivalent preferred
• Specialty training as applicable

Experience

• Regulatory experience (IND management/Clinical/CMC)
• 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 $110,000.00/Yr.

Compensation Range: Max

USD $130,000.00/Yr.