Buffalo Grove, Illinois, United States · On-site
$210k–$330k/yr
Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using …
Skills: Clinical Strategy, IVD Product Development, FDA Regulatory Submissions, GCP, GLP
Decatur, Illinois, United States · On-site
$25/hr–$27/hr
Line of Business: Other About Us Heidelberg Materials is one of the world's largest suppliers of building materials. Heidelberg Materials North America operates over 450 locations across the U.S. and Canada with approxim…
Skills: Heavy Equipment Operation, Mechanical Aptitude, Problem Solving, Communication, Organizational Skills
Morton Grove, Illinois, United States · On-site
$111k–$120k/yr
Job DetailsJob Location: Morton Grove, IL 60053Education Level: 4 Year DegreeSalary Range: $111,000.00 - $120,000.00 Salary/yearJob Shift: 1stFareva Morton Grove is seeking an experienced financial professional that will…
Skills: Financial Analysis, SAP, Consolidation Accounting, Cross-functional Collaboration, PowerPoint
Morton Grove, Illinois, United States · On-site
$111k–$120k/yr
Job DetailsJob Location: Morton Grove, IL 60053Education Level: 4 Year DegreeSalary Range: $111,000.00 - $120,000.00 Salary/yearJob Shift: 1stFareva Morton Grove is seeking an experienced financial professional that will…
Skills: Financial Analysis, SAP, Consolidation Accounting, Cross-functional Collaboration, PowerPoint
Monmouth, Illinois, United States · On-site
$14/hr–$24/hr
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. Have a seat at our table. When you join Smithfield, you become part of something special – a company …
Skills: Microsoft Excel, Microsoft Word, 10-key Adding Machine, Data Entry, Invoicing
Orland Park, Illinois, United States · On-site
At Panduit, we don’t just offer a job – we offer a career where your contributions directly impact our customers, the environment and our company’s success. You’ll have the opportunity to grow, innovate, and be a part of…
Skills: Machine Operation, Troubleshooting, Lean Tools, Quality Control, 5S Efficiency
Bellwood, Illinois, United States · On-site
$18/hr–$26/hr
Position Requirements Perform duties to inspect a variety of one -way clutch assemblies and component to ensure conformance with company standards, Military standards and customer specifications. Package and prepare unit…
Skills: Aircraft Component Inspection, Precision Measurement, Calibration, Blueprint Reading, Quality Control
Elgin, Illinois, United States · On-site
$25/hr–$35/hr
Shift: Sunday - Thursday; 1:30pm - 10:00pm (or until work is complete for the day) Sunday start time 6am What Warehouse Operations contributes to Cardinal Health Operations are responsible for materials handling and prod…
Skills: Warehouse Management, Inventory Control, Workflow Direction, Productivity Analysis, Workload Forecasting
Rolling Meadows, Illinois, United States · On-site
Position Responsibilities: Perform machine set-up/changeover to produce the required product or components by making mechanical adjustments to meet product specifications.Perform first time set-up of equipment for new pr…
Skills: Machine Set-up, Machine Operation, Programming, Profiling, Blueprint Reading
Rolling Meadows, Illinois, United States · On-site
$71k–$95k/yr
Position Responsibilities: Serve as the primary point of contact for customer communication, ensuring timely and accurate information sharing. Implement and oversee project management activities for assigned customer pro…
Skills: Customer Service, Project Management, Order Management, Production Planning, Relationship Building
Danville, Illinois, United States · Hybrid
Job Title Dealer Contact I Job Category Supply Chain Management Job Description What starts with YOU, moves the world! Hyster-Yale Materials Handling, Inc, a world-class manufacturer of industrial lift trucks, has an out…
Skills: Customer Service, Relationship Management, Problem Solving, Critical Thinking, Written Communication
Springfield, Illinois, United States · On-site
$37/hr–$44/hr
Working Hours/Days8:00 am – 4:30 pm Monday - Friday, overtime and weekends as needed Basic Duties Perform service and repairs on Caterpillar and other types of heavy equipment. Trouble-shoot and repair engine, hydraulic,…
Skills: Heavy Equipment Repair, Engine Diagnostics, Hydraulic Systems, Electrical Troubleshooting, Customer Service
Buffalo Grove, Illinois, United States · On-site
Overview Wieland - Creating Value for Generations! Wieland is a global leader in copper and copper alloy manufacturing, processing, and distribution. We provide a large product and service portfolio including power, auto…
Skills: CNC Machining, Quality Inspection, Troubleshooting, Overhead Crane Operation, Measurement Math
Libertyville, Illinois, United States · On-site
$65k–$80k/yr
Job DetailsJob Location: UCC Libertyville - Libertyville, IL 60048Salary Range: $65,000.00 - $80,000.00 Salary/yearJoin UCC Environmental, a leader in sustainable technology solutions: Looking for a career where your wor…
Skills: Parts Application, Customer Service, Technical Support, ERP Systems, Reading Engineering Drawings
Tinley Park, Illinois, United States · On-site
$200k–$215k/yr
Job DetailsJob Location: Tinley Park Corporate Office - Tinley Park, IL 60477Position Type: Full TimeSalary Range: $200,000.00 - $215,000.00 Salary/yearJob Shift: 1stJob Category: AccountingAbout Us: Carl Buddig and Comp…
Skills: Financial Strategy, Accounting Operations, Financial Planning and Analysis, Budgeting, Forecasting
Tinley Park, Illinois, United States · On-site
$200k–$215k/yr
Job DetailsJob Location: Tinley Park, IL 60477Position Type: Full TimeSalary Range: $200,000.00 - $215,000.00 Salary/yearJob Shift: 1stJob Category: AccountingAbout Us: Carl Buddig and Company, a respected name in the me…
Skills: Financial Strategy, Accounting Operations, Financial Planning and Analysis, Budgeting, Forecasting
Cary, Illinois, United States · On-site
Entry Level Manufacturing 1st/2nd Shift Composed of Chromalox, Durex Industries, Vulcanic, and Thermocoax businesses, Electrical Thermal Solutions (ETS), part of Spirax Group, creates electrical process heating and tempe…
Skills: Production Equipment Operation, Component Assembly, Forming Processes, Casting Processes, Quality Inspection
Cary, Illinois, United States · On-site
Material Handler Composed of Chromalox, Durex Industries, Vulcanic, and Thermocoax businesses, Electrical Thermal Solutions (ETS), part of Spirax Group, creates electrical process heating and temperature management solut…
Skills: Material Handling, Inventory Management, Cycle Counting, Quality Inspection, Shipping and Receiving
Cary, Illinois, United States · On-site
TBC Composed of Chromalox, Durex Industries, Vulcanic, and Thermocoax businesses, Electrical Thermal Solutions (ETS), part of Spirax Group, creates electrical process heating and temperature management solutions, includi…
Skills: Thermal Control, Engineering Design, Manufacturing, Quality Assurance, Testing
Cary, Illinois, United States · On-site
Material Handler Composed of Chromalox, Durex Industries, Vulcanic, and Thermocoax businesses, Electrical Thermal Solutions (ETS), part of Spirax Group, creates electrical process heating and temperature management solut…
Skills: Material Handling, Inventory Management, Cycle Counting, Quality Inspection, Shipping and Receiving
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The Senior Director is responsible for developing and executing the clinical strategy for new and modified IVD products, including preclinical and clinical evaluation plans. They will also oversee the operations of the Sysmex RACA Laboratory and serve as the Principal Investigator for IRB-approved studies.
Requires a Master's degree (PhD desired) and at least 15 years of clinical research experience, with 8 years in a leadership role. Candidates must have in-depth knowledge of GCP, GLP, and FDA regulations specifically related to IVD products.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
We currently have a great opportunity available for a Senior Director, Clinical Affairs. The Senior Director, Clinical Affairs will be responsible for developing, coordinating, and executing the clinical strategy for new and modified Sysmex IVD products. This position will be responsible for understanding the operating principles of the devices required, to develop preclinical and clinical evaluation plans including study protocols; determine study documentation requirements; and generate final reports and sections of FDA applications. The position will also be responsible for ensuring the operations of the Sysmex clinical laboratory, including functioning as the Principal Investigator for IRB-approved studies conducted in the RACA Laboratory. The Senior Director will also be responsible for maintaining relationships with outside institutions required to conduct the evaluations.
1. Direct and comply with all policies, established procedures, and regulations related to the studies. Maintain professional, product and market expertise via independent reading, networking and training. 2. Develop and execute clinical strategy for new/modified Sysmex IVD products including the development of preclinical and clinical evaluation plans in compliance with FDA and CLSI guidelines, GCP requirements, and recent FDA submissions for similar products. Function as a Subject Matter Expert where appropriate. Integrate clinical strategy with colleagues at S-Corp and other Sysmex Affiliates.3. Execute evaluations as above in alignment with business goals and objectives. Responsible for establishing, managing, and achieving project milestones with internal staff, other departments, and all study investigators and research coordinators.4. Ensure that associates are accountable for timely development of clinical trial documentation including instructions for use, case report forms (CRFs), CRF guidelines, informed consent, monitoring plans and reports, assisting with study protocol development and other necessary clinical/regulatory documentation. Mentor and support staff to achieve success and excellence in these areas.5. Oversee the progress of projects and assures adherence to intended timelines including enrollment, clinical supplies, and data management/delivery. Identify issues that may impact the overall project plan and initiate contingency plans, communicate with leadership, as appropriate.6. Direct the operations of the Sysmex RACA Laboratory in close alignment with the Laboratory Manager and function as the Principal Investigator for IRB-approved studies.7. Establish and maintain relationships with outside institutions required to conduct the appropriate evaluations including recruiting investigational sites, negotiating and maintaining budgets and contracts. 8. Contribute to clinical sections of regulatory submissions 9. Generate and author final reports appropriate to support regulatory filings.10. Other duties as required.
Percentage of Travel: Up to 35% of time
Physical Risk: Regular exposure to risk that may require alertness, but with minimal precautions.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Master’s degree required (Medical/Science background highly desired), PhD degree desired. A minimum of 15+ years of clinical research experience required with minimum of 8 years’ experience leading clinical projects, including experience in the Armed Forces.
Experience in all aspects of preclinical and clinical study evaluations.
Technical laboratory instrument expertise/experience.
In depth knowledge of regulations and industry standards affecting preclinical and clinical studies of IVD products, including GCP & GLP.
Technical expert in the various aspects of the clinical evaluation process.
History of significant contribution to the success of planning and executing clinical strategies in support of product clearance.
Knowledge of regulations and standards affecting clinical and preclinical studies of Sysmex products.
English
Excellent general IT skills i.e. Microsoft Office/Outlook, Adobe etc. and basic statistics.Laboratory &/or LIS computer skills would be a plus.
Ability to follow guidelines and effectively communicate scientific data in a structured manner. Understands and interprets scientific data related to regulatory requirements and strategy and provides knowledge and expertise to guide others
Strong interpersonal skills, ability to interface effectively with all levels of staff and management, both internally and externally.
Excellent organizational skills and attention to detail.
Ability to manage multiple priorities.
The salary range for this role is $210,000 – 330,000. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.
This job requires satisfaction of the credentialing requirements of Sysmex’s customers, including hospitals and other healthcare facilities, which generally includes proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID-19.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Together for a better healthcare journey
Sysmex Corporation is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives. Read our Social Media Policy here: https://www.sysmex.co.jp/en/policy.html
Offices: 1-5-1, Wakinohama-Kaigandori, Chuo-ku, Kobe, Hyogo 651-0073 , JP · 4丁目4番地の4, 高塚台, 神戸市西区, 兵庫県 651-2271, JP · 1丁目3番地の2, 室谷, 神戸市西区, 兵庫県 651-2241, JP
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