Precision for Medicineis the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.Position Summary:The Senior Director of Operations, Central Lab Services will provide strategic and scientific oversight and assume ultimate responsibility for the daily operations of global PBMC Isolations and all sample processing operations within the Precision for Medicine labs. The incumbent will also be responsible for overseeing, coordinating and long-term development of affiliate network laboratories known as the Precision Lab Network (PLN). This role will provide oversight to all assigned teams, including the Biorepository assuring compliance with applicable regulations, licensing agencies, global Standard Operating Procedures, quality control, as well as development, and successful implementation, of any new central laboratory services and processes. The incumbent will be expected to align and standardize processes with all other Precision for Medicine labs. The incumbent will manage regulatory compliance, as required to maintain appropriate standards (e.g., College of American Pathologists (CAP) and GCLP for handling samples from clinical studies.This position is a member of the Central Lab Services Senior Management Team, and as such, holds a critical role with regards to responsibility and accountability necessary for the successful development of the business, including the promotion of a professional, respectful, results-oriented work environment. The ability to work in a matrix environment, and the ability to achieve positive results through influencing other teams, and team members, is critical.Essential functions of the job include but are not limited to: Department Management & Oversight:Lead, manage and allocate appropriate resources, including personnel and facilities, in a cost-efficient manner in order to achieve successful and timely completion of all projects, contracts, and department objectives inclusive of the Precision Lab Network labs and sample handling and sample preparation processes (e.g., PBMC preparation, sample fractionation and aliquoting).Provide scientific oversight and communicate with clients regarding any technical issues with cell isolations and sample handling and utility for planned downstream assays.Ensure maintenance of client sample integrity and data accuracy through implementation of appropriate quality control measures, for all sample handling and sample preparation procedures, and adherence to all quality control procedures and guidelines.Analyze operations and generate metrics on an ongoing basis to build a continuous improvement environment.Coordinate with other departments regarding available resources and needs.Interact with, and present to, clients.Enforce CAP/GxP/ISO regulations and standards within all aspects of the department.Maintain and support safe lab practices and safe environment.Successfully provide oversight to remote operations.Lead and manage staff in keeping with expressed objectives and corporate culture, and in doing so provide a workplace where ideas are sought and considered, initiative is encouraged, success is rewarded, and employees are treated fairly, with respect and recognition.Department Training, Planning & Reporting:Define and communicate departmental goals/objectives and establish annual departmental plan.Prepare monthly performance, volume and quality metrics as required for sample processing/preparation and Precision Lab Network labs.Provide regular updates outlining accomplishments, progress, challenges, needs, etc.Participate in preparing annual departmental budget and cost estimates as required.Participate in appropriate Central Lab Services strategic planning activities.Business & Scientific Development:Directly responsible for oversight of incoming biospecimens, accessioning and storage of biospecimens, freezer inventory and monitoring, and preparing outbound shipments.Provide technical oversight and expertise in sterile technique and cell-based sample isolation and testing procedures.Demonstrate a strong understanding of implementation, documentation, and oversight of sample traceability processes.Make recommendations to upper management for strategic growth opportunities.Optimize and expand operations that are relevant to corporate goals.Carry out other duties/projects as assigned.Qualifications:Minimum Required:Master's Degree and 10 years' relevant experience orBachelor's and 12 years' relevant experience5+ years of Cell Biology experience in performing, implementing, and overseeing laboratory techniques and familiarity with PBMC isolation.3+ years' experience in Project Management or other client engagement in a scientific or technical disciplineMust have senior level strategically focused operational experience with equivalent experience in a biological laboratory.Must understand basic laboratory principles and must have knowledge of safety and regulatory requirements for preparation and handling of human specimens.Other Required:All aspects of highly developed interpersonal, communication and management skills are required.Sample preparation and processing experience with working knowledge of how to collect and process clinical specimens for translational research.Experience working in a global environment, successfully executing the standardization and global alignment of processes.Must have demonstrated expertise in his/her scientific discipline, as well as a solid understanding of current CAP and GCLP standards. Working knowledge of CLIA and ISO regulations is an advantage.Proven experience managing and/or overseeing management of multiple projects simultaneously.Substantial knowledge and understanding of specimen collection, preparation, processing and handling factors that affect specimen integrity required.Confidentiality, excellent use of judgment and discretion required relative to sensitive and restricted Company and employee information.Excellent communication, interpersonal, organizational and multi-tasking skills,Must possess strong computer skills including Microsoft Office SuiteAble to travel both domestically and internationally including overnight stays.Must be able to read, write, speak fluently and comprehend the English language.
