Chair, Institutional Biosafety Committee

At Sabai Global, our mission is to provide the clinical research community with superior expertise and white-glove service for ethical review and biosafety support. We are searching for a CHAIR for our INSTITUTIONAL BIOSAFETY COMMITTEE.

ROLE and RESPONSIBILITIES:

• Under the direction of the Regulatory Director, professionally chairs Institutional Biosafety Committee (IBC) meetings with pre and postmeeting review.
• Authors comprehensive, highquality Risk Assessments for clinical trials and basic research programs under Company oversight.
• Ensures timely preparation, review, and submission of documents to regulatory authorities and maintaining compliance with regulatory requirements.
• Provides significant decisionmaking capabilities, highlevel judicial and analytical capabilities, ability to apply own ethical principles and sound judgement to unique situations in IBC reviews.
• Provides expertlevel understanding of risk management with innovative forwardplanning ability to apply a deep and profound understanding of the sector and the industry to address compliance issues where they arise.
• Ensures readiness for successful IBC review of clinical trials.
• Determines if changes to existing IBC approvals need to be reviewed at a convened meeting.
• May serve on Sabai IRB in review of Human Gene Transfer (HGT) clinical trials; may assist Sabai Institutional Review Board in an ad hoc subject matter expert consultant capacity with respect to HGT clinical trials.
• Supports development of Policies & Procedure for Sabai and subsidiaries.
• Stays up to date on applicable regulatory changes as well as technical and scientific aspects of biological safety standards and developments.
• Provides highly effective communication skills.
• Interfaces and builds strong relationships with external regulatory groups at institutions and research organizations.
• Works cohesively with, and supports, other departments within the organization (e.g., Client Services, Business Development, Quality Assurance).

EDUCATIONAL REQUIREMENTS:

• Requires a terminal degree, such as PhD, MD, JD, PharmD, RPh, DrPH, with experience strongly preferred in life sciences.

PREFERRED QUALIFICATIONS:

• Registered Biosafety Professional (RBP) or Certified Biological Safety Professional (CBSP) is preferred.
• Certified IRB Professional (CIP) a plus.
• At least 7 plus years experience in research, research safety, infection prevention, regulatory compliance, or clinical trial oversight preferred.
• Proven experience in serving as a Chair or Committee member of an Institutional Biosafety Committee (IBC).
• Experience in serving as a Committee member or ad hoc reviewer on an Institutional Review Board (IRB) a plus.
• Regulatory experience with biologics and cell & gene therapy a plus.
• Knowledgeable in applicable regulations and guidelines, including NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), and OSHA Standards related to biohazards and clinical practice.
• Familiar with general microbiology, safe handling of pathogens and biohazardous materials, decontamination, spill and exposure response, biosafety risk assessment, and biosafety training resources.
• Demonstrated project management and organizational skills; strong attention to detail and multitasking ability.
• Ability to work both independently (selfmotivated) and collaboratively in a team structure and thrive in a fastpaced environment.
• Effective problemsolving and excellent communication skills (both written and oral).
• Excellent organizational, computer and documentation skills and an ability to prioritize effectively

WORK LOCATION:

For applicants local to St. Louis, MO, this could be a hybrid role. Applicants in other locations would be fully remote.

About Sabai Global From our initial founding, Sabai has protected the safety, rights and welfare of those who participate in clinical trials and those that conduct the research. We began by providing biosafety services and oversight for institutions, and our uniquely personal approach to deep expertise and white-glove service soon drove expansion into IRB review and consulting. Today, we support sponsors and sites across all phases of research and all therapeutic areas, including biologics, human factors, devices and social behavioral research. We deliver a complete suite of services to our pharmaceutical and institution partners. Were proud to always remain a people-focused company. Through this principle we serve as a true partner to our clients—thoughtfully and expertly curating the best solutions to meet their needs, throughout the clinical trial process. We are Principled. We are Passionate. We are People-first. If all of this resonates with you, we would like to hear about your story.