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Laboratory Director

Employer
Proclinical Staffing
Location
York (UK)
Salary
Competitive Package
Start date
9 Jun 2021
Closing date
9 Jul 2021

View more

Discipline
R & D , Laboratory
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

SUMMARY

The Laboratory Director will oversee all Clinical Trials testing performed at our client's site in York (UK). The Laboratory Director will report directly to the Vice President of Clinical Lab Operations and is responsible for ensuring high-quality clinical trial testing, developing and expanding the service offers to meet the needs of patients/clients and is a critical member of the Senior Leadership Team. This position oversees and ensures laboratory compliance with all applicable regulatory agencies.

STATUS: Full-Time

LOCATION: York, UK

DEPARTMENT: Clinical Trials Laboratory

SCHEDULE: Monday – Friday

 

RESPONSIBILITIES

  • Leadership – Provide oversight and leadership while ensuring high-quality patient testing for clinical trials. Provide effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory. Direct and supervise technical performance of staff. Ensure staff competency and resources. Support continuing education of staff
  • Quality - Ensure laboratory compliance with all applicable regulatory agencies and guidelines, including but not limited to: NYS CLEP, College of American Pathologists (CAP), CLIA, FDA, ICH and specific state requirements of CA, FL, MD, ME, NJ, NY, OK, PA, RI, and VT. Guarantee laboratory compliance with Good Clinical Practice and Good Laboratory Practice. Ensure the implementation of a safe laboratory environment in compliance with good practice and applicable regulations. Oversee all aspects of the laboratory’s quality management program. Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills
  • Partnership - Collaborate with business and operational leaders to ensure the proper test offerings and to develop/introduce new technologies and develop new and novel assays. Partner with Scientific Affairs to ensure that the test menu is current. Partner with Laboratory Operations globally in the selection of all laboratory equipment, supplies, and services with respect to quality (or designee). Interact and maintain good relationships with applicable regulatory agencies as well as the professional community
  • Development & Validation - Work closely with and oversee the development of new testing methods for the laboratory and ensures that new testing methods/analytes are properly prioritized and works with finance and operations to assist in developing the ROI for new test offerings. Ensure that the performance specifications for new tests, instruments, and methods introduced to the laboratory have been properly validated or verified prior to being used for clinical trial testing. Ensure that proficiency testing, alternative assessment, and QC procedures are sufficient for the extent of testing performed in the laboratory.

 

REQUIREMENTS

Essential

  • Ph.D. in Biomedical Sciences, such as, Chemistry, Biology, Immunology, etc
  • 10 years’ experience in clinical trials, research and/ or clinical laboratory
  • Experience in Good Clinical Practice (GCP)
  • Experience in quality improvement implementation

Desired

  • 2 years of laboratory supervision
  • Good Laboratory Practice (GLP) and/or Good Clinical Laboratory Practice (GCLP)
  • Experience with College of American Pathology (CAP), Medicines & Healthcare products Regulatory Agency (MHRA), and/or Food & Drug Administration (FDA)

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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