Ed Steele Email & Phone Number

Us Regional

Us Regional

Us Regional

-Acts as the primary liaison between the company and the customer to ensure study launch, conduct, and closeout for studies ranging in size and complexity from single service studies to full scope, multiple protocol projects, and/or global projects, across various phases and functional areas. -Develops and maintains project plans and other tracking/analysis tools for the study to evaluate project progress, and reports status to the functional areas, sites, vendors, and customer. -Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses, and performs ongoing review of the project financial status. -Oversees the regulatory document collection and submission process, ensuring complete project documentation. -Develops strong client relationships and generates new business for the future.

Us Regional

Acts as the primary point of contact for Phase I-III clinical oncology projects and responsible for developing successful working relationships with clients. Responsible for managing cross functional project team, including planning, scheduling and implementation of cross functional projects and ensuring all necessary project training is provided to assigned staff. Responsible for defining project scope, resource requirements and deliverables, as well as development and oversight of risk mitigation strategies, associated action plan and issue resolution. Proactively manages study budget, changes in scope, invoicing procedures and collaborates with Business Development to ensure timely completion of change orders. Monitors and reports on progress of the project and quality metrics to all stakeholders and participates in business development activities, including bid defense, kick off meetings etc.

Responsible for the oversight and management of clinical and data services for individual trial and program activities throughout the study life cycle for Phase 1 and 2a clinical trials in healthy volunteers and patient populations. This includes serving as primary client contact and responsibility for the facilitation of communication, managing client expectations, and building business relationships. Responsible for the management of clinical trials in both patients and healthy volunteers for compounds focusing in Oncology, Alzheimer’s, Diabetes, Autoimmune, IBD/UC/Crohn’s, Parkinson’s, MS, RA and other indications. Oversees multiple compounds under development on a program management level for dedicated client, coordinating activities to meet submission timelines. Develops and manages protocols, scope of project and project components, budgets, timelines, deliverables and quality guidelines thereby ensuring expectations are met while identifying and mitigating risks. Leads bid defense and other business development activities. Responsible for communication within the Covance organization regarding study progress, client requirements, and feedback, as well as liaising with external data vendors and other Covance offices.

Provided oversight and coordination of In-life study management for all activities from scheduling to necropsy per GLP, USDA, AALAC requirements. Responsible for Global NonHuman Primate DART In-life department development and working with international counterparts to foster cross-functional teamwork for project success. Responsible for hiring technical staff, consulting with internal and external clients about needs and requirements, and the development of non-standard procedures when necessary. Monitored financial expenses and budgets for the department, conducted client and QA tours as a representative for the department, and assisted in managerial duties in support of upper management as needed.

Responsible for all activities from scheduling to necropsy, and review of the final in-life product, ensuring compliance with all procedures relevant to animal operations including Good Laboratory Practices (GLPs), department standard operating procedures (SOPs), Policies and Procedures (P&Ps), the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International), and USDA requirements. Responsible for hiring technical staff, consulting with internal and external clients about needs and requirements, and the development of non-standard procedures when necessary. Monitors financial budgets and expenses, conducts client tours, and assists in managerial duties in support of upper management as needed.

Responsible for the effective operation of a toxicology group. Planned, scheduled, and organized necessary resources for study conduct and assignments and implemented department policies to maintain facilities and equipment. Other duties include writing and reviewing SOPs, planning space allocations, and recommending changes and leads in the development and execution of new methods in the laboratory. Assured that the assigned projects were in compliance with established protocols, SOPs, the GLPs, and other appropriate regulations. Monitored to ensured the staff was trained and proficient in all phases of applicable laboratory.operations.

Manage the In-Life portion of preclinical research and a group of study technicians that collect data to support drug development. Responsible for a group of laboratory technicians, including preparing staff daily assignments, conducting performance reviews, recruiting new employees, and preparing training plans. Assisted in conducting routine toxicology studies, ordering equipment, determining space availability, and maintained equipment inventory. Reviewed data books for standard operating procedures (SOPs) and protocol compliance.

Co-founded a small biotech start-up focused on developing custom enzymatic solutions for industrial, bio-fuels, and clinical applications. The experiences I gained with regards to the challenges one faces in starting a business and developing a company's identity will be ones that I retain and value my entire life.

Responsible for supervising 25+ Animal Research Technicians who are responsible for the total basic care of a colony of +1500 research monkeys. The facility, one of the eight federally funded Primate Research Centers, houses animals in BSL 2/3 conditions and conducts a wide range of research, including Parkinson's Disease, SIV/AIDS vaccine research and Aging studies.Supervisory duties include: interview and hire new staff as needed, discipline/dismiss staff as needed, management representative for union negotiations, SOP review/creation, annual performance reviews of staff, training staff on new procedures, maintain standards of animal care compliant with accreditation (AALAS, IACUC, Graduate School, USDA, etc.), schedule/organize weekend work schedules for 25+ employees

Part of a research group that provided research support to Principal Investigators at the Wisconsin National Primate Research Center, in such diverse fields as Parkinson's disease, stem cell and AIDS research, anti-obesity and metabolic studies and reproductive research.Responsibilities included a wide range of research, as both a project manager coordinating research activities as well as assisting and carrying out procedures independently under many different protocols on sedated and cognizant animals.

Responsible for the total basic care of rhesus macaques, including dietary needs, daily health observations, sanitation and safety. Administered medications to animals and assisted in animal procedures, including: special procedures for infants, breeding activities and the diagnosis of pregnancy via ultrasound, tuberculosis testing procedures, training adult rhesus males for semen collection, blood sampling and implanting identification transponder microchips.

M.S., Biotechnology

The Biotechnology Masters Degree program focused on regulatory aspects, business development and scientific operations. Hands-on classes.

B.S., Zoology, Biological Aspects Of Conservation, Anthropology

Triple majored in Zoology, Biological Aspects of Conservation and Anthropology. Volunteered in an Arctic Archeology Anthropology Lab for 2.